Fluid dispensing device

ABSTRACT

A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as antibiotics, blood clotting agents, analgesics, and like medicinal agents from collapsible containers at a uniform rate. The dispenser includes a novel stored energy source that is provided in the form of a compressible-expandable member that functions to continuously and uniformly expel fluid from the device reservoir. The apparatus further includes a novel fluid flow control assembly that precisely controls the flow of the medicament solutions from the device reservoir to the patient.

This is a Non-Provisional Application claiming the benefit of co-pendingProvisional Application No. 60/783,182 filed Mar. 15, 2006.

SPECIFICATION

1. Field of the Invention

The present invention relates generally to fluid dispensing devices.More particularly, the invention concerns medicament dispensers fordispensing medicinal fluids to ambulatory patients.

2. Discussion of the Prior Art

A number of different types of medicament dispensers for dispensingmedicaments to ambulatory patients have been suggested in the past. Manyof the devices seek either to improve or to replace the traditionalgravity flow and hypodermic syringe methods which have been the standardfor delivery of liquid medicaments for many years.

The prior art gravity flow methods typically involve the use ofintravenous administration sets and the familiar flexible solution bagsuspended above the patient. Such gravametric methods are cumbersome,imprecise and require bed confinement of the patient. Periodicmonitoring of the apparatus by the nurse or doctor is required to detectmalfunctions of the infusion apparatus. Accordingly, the prior artdevices are not well suited for use in those instances where the patientmust be transported to a remote facility for treatment.

As will be fully appreciated from the discussion that follows, thedevices of the present invention are particularly useful in ambulatorysituations. The ability to quickly and efficaciously treat woundedsoldiers, especially in unpredictable or remote care settings, cansignificantly improve chances for patient survival and recovery.Accurate intravenous (IV) drug and fluid delivery technologies forcontrolling pain, preventing infection, and providing a means for IVaccess for rapid infusions during patient transport are needed to treatalmost all serious injuries.

It is imperative that battlefield medics begin administering life savingmedications as soon as possible after a casualty occurs. The continuousmaintenance of these treatments is vital until higher echelon medicalfacilities can be reached. A compact, portable and ready to use infusiondevice that could be easily brought into the battlefield would allowmedics to begin drug and resuscitation agent infusions immediately.Additionally, it would free them to attend to other seriously woundedpatients who may require more hands-on care in the trauma environmentfollowing triage. In most serious trauma situations on the battlefield,IV drug delivery is required to treat fluid resuscitation, as well asboth pain and infection. Drug infusion devices currently available canimpede administration of IV infusions in remote care settings.

Expensive electronic infusion pumps are not a practical field solutionbecause of their weight and cumbersome size. Moreover, today'sprocedures for starting IV infusions on the battlefield are oftendangerous because the attending medic must complete several timeconsuming steps. The labor intensive nature of current gravity solutionbag modalities can prevent medics from attending to other patients alsosuffering from life threatening injuries. In some cases, patientsthemselves have been forced to hold flexible infusion bags elevated, inorder to receive the medication by gravity drip.

With regard to the prior art, one of the most versatile and unique fluiddelivery apparatus developed in recent years is that developed by one ofthe present inventors and described in U.S. Pat. No. 5,205,820. Thecomponents of this novel fluid delivery apparatus generally include: abase assembly, an elastomeric membrane serving as a stored energy means,fluid flow channels for filling and delivery, flow control means, acover, and an ullage which comprises a part of the base assembly.

Another prior art patent issued to one of the present applicants, namelyU.S. Pat. No. 5,743,879, discloses an injectable medicament dispenserfor use in controllably dispensing fluid medicaments such as insulin,anti-infectives, analgesics, oncolylotics, cardiac drugsbiopharmaceuticals, and the like from a pre-filled container at auniform rate. The dispenser, which is quite dissimilar in constructionand operation from that of the present invention, includes a storedenergy source in the form of a compressively deformable, polymericelastomeric member that provides the force necessary to controllablydischarge the medicament from a pre-filled container, which is housedwithin the body of the device. After having been deformed, thepolymeric, elastomeric member will return to its starting configurationin a highly predictable manner.

SUMMARY OF THE INVENTION

By way of brief summary, one form of the dispensing device of thepresent invention for dispensing medicaments to a patient comprises asupporting structure; a carriage assembly interconnected with thesupporting structure for movement between a first position and a secondposition; a pre-filled collapsible container carried by the carriageassembly, the collapsible container having accessing means for accessingthe reservoir comprising a frangible member in the form of a pierceablemember or a shearable member. The device also includes a guide meansconnected to the supporting structure for guiding travel of the carriageassembly between the first position and said second positions; a storedenergy source operably associated with the carriage assembly for movingthe carriage assembly between the first and second positions; and anadministration set, including an administration line interconnected withthe outlet port of the collapsible reservoir.

With the forgoing in mind, it is an object of the present invention toprovide a compact fluid dispenser for use in controllably dispensingfluid medicaments to ambulatory patients, such as, antibiotics, bloodclotting agents, analgesics, KVO, artificial blood substitutes,resuscitation fluids, nutritional solutions, biologics, and like agentsfrom pre-filled containers at a uniform rate.

Another object of the invention is to provide a small, compactpre-filled fluid dispenser that is aseptically filled and sealed at thetime of manufacture.

Another object of the invention is to provide a fluid dispenser ofsimple construction that can be used in the field with a minimum amountof training.

Another object of the invention is to allow infusion therapy to beinitiated quickly and easily on the battlefield so that the attendingmedic or medical professional can more efficiently deal with triagesituations in austere environments.

Another object of the invention is to provide a dispenser in which astored energy source is provided in the form of a compressible,expandable or retractable member of novel construction that provides theforce necessary to continuously and uniformly expel fluid from thedevice reservoir.

Another object of the invention is to provide a dispenser of the classdescribed which includes a fluid flow control assembly that preciselycontrols the flow of the medicament solution to the patient.

Another object of the invention is to provide a dispenser that includesprecise variable flow rate selection.

Another object of the invention is to provide a fluid dispenser ofsimple construction, which embodies a collapsible, pre-filled, sealeddrug container that contains the beneficial agents to be delivered tothe patient. Uniquely, the container is formed as a unitary structurethat includes a collapsible side wall and pierceable closure wall thatisolates the beneficial agents contained within the container reservoirfrom external contaminants.

Another object of the invention is to provide a fluid dispenser asdescribed in the preceding paragraph, which embodies a collapsible,pre-filled drug container that includes an integrally formed, sealedreservoir that contains the beneficial agents to be delivered to thepatient and is provided with access assemblies of various configurationsthat enable ready access to the sealed reservoir be penetratingassemblies various configurations.

Another object of the invention is to provide a fluid dispenser of theclass described which is compact, lightweight, is easy for ambulatorypatients to use, is fully disposable, transportable, and is extremelyreliable in operation.

Another object of the invention is to provide a fluid dispenser asdescribed in the preceding paragraphs that is easy and inexpensive tomanufacture in large quantities.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective top view of one form of the fluiddispensing device of the present invention for dispensing medicaments toa patient.

FIG. 2 is a generally perspective bottom view of the fluid dispensingdevice shown in FIG. 1.

FIG. 3 is a generally perspective view of the fluid dispensing deviceshown in FIG. 1 as it appears with the top cover of the device removed.

FIG. 4 is an enlarged, foreshortened, longitudinal, cross-sectional viewof the pre-filled fluid dispensing device illustrated in FIG. 1.

FIG. 5 is a longitudinal, cross-sectional view similar to FIG. 4, butshowing the various components of the device as they appear followingdelivery to the patient of the fluid contained within the devicereservoir.

FIG. 6 is a cross-sectional view taken along lines 6-6 of FIG. 5.

FIG. 7 is a cross-sectional view taken along lines 7-7 of FIG. 5.

FIG. 8 is a generally perspective, exploded view of the fluid deliverydevice illustrated in FIG. 3.

FIG. 9 is a top plan view of the fluid reservoir assembly of theinvention.

FIG. 10 is a cross-sectional view taken along lines 10-10 of FIG. 9.

FIG. 11 is an enlarged cross-sectional view of the area designated inFIG. 10 by “11”.

FIG. 12 is a side elevational view of one form of the control shaft ofthe flow control means of the invention.

FIG. 13 is a view taken along lines 13-13 of FIG. 12.

FIG. 14 is a view taken along lines 14-14 of FIG. 12.

FIG. 15 is an enlarged cross-sectional view taken along lines 15-15 ofFIG. 12.

FIG. 16 is an enlarged front view of one form of the spring knife of theinvention that is carried within cavities formed in the control shaftshown in FIG. 12.

FIG. 17 is a view taken along lines 17-17 of FIG. 16.

FIG. 18 is an enlarged cross-sectional view of a portion of the supportstructure and of the control shaft of the device illustrating theappearance of the components in their starting position.

FIG. 19 is a cross-sectional view similar to FIG. 18 but showing theappearance of the components after the initial rotation of the controlshaft from a first position to a second position.

FIG. 20 is a cross-sectional view similar to FIG. 19 but showing theappearance of the components after further rotation of the control shaftfrom the second position to a third position.

FIG. 21 is a top plan view of the operating handle of the device that isused for rotating the control shaft.

FIG. 22 is a view taken along lines 22-22 of FIG. 21.

FIG. 23 is a top plan view of one form of the selector member of thedevice for selecting the rate of fluid flow toward the patient.

FIG. 24 is a cross-sectional view taken along lines 24-24 of FIG. 23.

FIG. 24A is a view taken along lines 24A-24A of FIG. 24.

FIG. 24B is a cross-sectional view taken along lines 24B-24B of FIG. 24.

FIG. 25 is a view taken along lines 25-25 of FIG. 24.

FIG. 26 is a top plan view of the retainer member of the device whichfunctions to retain the selector member in position.

FIG. 27 is a cross-sectional view taken along lines 27-27 of FIG. 26.

FIG. 27A is a cross-sectional view taken along lines 27A-27A of FIG. 26.

FIG. 28 is a top plan view of the selector member housing of the device.

FIG. 29 is a cross-sectional view taken along lines 29-29 of FIG. 28.

FIG. 30 is a view taken along lines 30-30 of FIG. 29.

FIG. 31 is a top plan view of the rate control housing of the devicewhich houses the rate control assembly.

FIG. 32 is a cross-sectional view taken along lines 32-32 of FIG. 31.

FIG. 33 is a view taken along lines 33-33 of FIG. 32.

FIG. 34 is a top plan view of a portion of the supporting structure ofthe device shown in FIG. 1.

FIG. 35 is a cross-sectional view taken along lines 35-35 of FIG. 34.

FIG. 35A is a view taken along lines 35A-35A of FIG. 35.

FIG. 36 is a top plan view of the rate control assembly of the presentform of the invention.

FIG. 37 is a cross-sectional view taken along lines 37-37 of FIG. 36.

FIG. 38 is a view taken along lines 38-38 of FIG. 37.

FIG. 39 is a top plan view of the upper cover of the rate controlassembly shown in FIG. 36.

FIG. 40 has a cross-sectional view taken along lines 40-40 of FIG. 39.

FIG. 41 is a view taken along lines 41-41 of FIG. 40.

FIG. 42 is a top plan view of one form of the rate control plate of therate control assembly of the invention.

FIG. 43 is a cross-sectional view taken along lines 43-43 of FIG. 42.

FIG. 44 is a view taken along lines 44-44 of FIG. 43.

FIG. 45 is a top plan view of the bottom cover of the rate controlassembly of the invention.

FIG. 46 is a cross-sectional view taken along lines 46-46 of FIG. 45.

FIG. 47 is a view taken along lines 47-47 of FIG. 46.

FIG. 47A is an exploded, generally perspective, diagrammatic view ofrate control portion of the device of the invention illustrating themanner of fluid flow from the device reservoir toward the administrationset of the invention.

FIG. 48 is a top plan view of the carriage component of the device ofthe invention which supports the reservoir assembly.

FIG. 49 is a cross-sectional view taken along lines 49-49 of FIG. 48.

FIG. 50 is a top plan view of a portion of the structural support of thedevice of the invention which supports the carriage component shown inFIGS. 48 and 49.

FIG. 51 is a foreshortened, cross-sectional view taken along lines 51-51of FIG. 50.

FIG. 52 is a view taken along lines 52-52 of FIG. 51.

FIG. 53 is cross-sectional view of the locking means of the inventionfor releasably locking the carriage to the portion of the structuralsupport shown in FIGS. 50 and 51.

FIG. 54 is a view taken along lines 54-54 of FIG. 53.

FIG. 55 is a view taken along lines 55-55 of FIG. 53.

FIG. 56 is an enlarged, foreshortened, longitudinal, cross-sectionalview of an alternate form of the fluid dispensing device of theinvention.

FIG. 57 is a longitudinal, cross-sectional view similar to FIG. 56, butshowing the various components of the device as they appear followingdelivery to the patient of the fluid contained within the devicereservoir.

FIG. 58 is a cross-sectional view of the collapsible container of thisalternate embodiment of the invention.

FIG. 59 is a top plan view of the collapsible container.

FIG. 60 is a cross-sectional view taken along lines 60-60 of FIG. 59.

FIG. 61 is a cross-sectional view of the area designated as “61” in FIG.60.

FIG. 62 is a generally perspective view of this alternate embodiment ofthe invention as it appears with the top cover of the device removed.

FIG. 63 is a longitudinal cross-sectional view of still another form ofthe fluid dispensing device of the invention.

FIG. 64 is a longitudinal cross-sectional view similar to FIG. 63 butshowing the various components of the device as they appear followingdelivery to the patient of the fluid contained within the devicereservoir.

FIG. 65 is a view taken along lines 65-65 of FIG. 64.

FIG. 66 is a view taken along lines 66-66 of FIG. 64.

FIG. 67 is a cross-sectional view of the collapsible container of thislatest form of the invention.

FIG. 68 is a top plan view of the collapsible container shown in FIG.67.

FIG. 69 is a cross-sectional view taken along lines 69-69 of FIG. 68.

FIG. 70 is a top plan view of the pierceable septum of the collapsiblecontainer shown in FIG. 67.

FIG. 71 is a cross-sectional view taken along lines 71-71 of FIG. 70.

FIG. 72 is a bottom plan view of the septum penetrating assembly of thislatest form of the invention.

FIG. 73 is a cross-sectional view taken along lines 73-73 of FIG. 72.

FIG. 74 is a view taken along lines 74-74 of FIG. 73.

FIG. 75 is a generally perspective view of this latest embodiment of theinvention as it appears with a top cover of the device removed.

FIG. 76 is an enlarged, foreshortened, longitudinal, cross-sectionalview of the fluid dispensing device of this latest embodiment theinvention illustrating the removal of the tear off strip of the device.

FIG. 77 is a foreshortened, longitudinal, cross-sectional view of analternate form of the fluid dispensing device of the invention.

FIG. 78 is a foreshortened longitudinal, cross-sectional view similar toFIG. 77, but showing the various components of the device as they appearfollowing delivery to the patient of the fluid contained within thedevice reservoir.

FIG. 79 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 80 is a cross-sectional view taken along lines 80-80 of FIG. 79.

FIG. 81 is an exploded, cross-sectional view of the reservoir accessassembly of this latest form of the invention.

FIG. 82 is a fragmentary, cross-sectional view of the collapsiblecontainer as it appears in the collapsed configuration.

FIG. 83 is a foreshortened, longitudinal, cross-sectional view of yetanother alternate form of the fluid dispensing device of the invention.

FIG. 84 is a foreshortened longitudinal, cross-sectional view similar toFIG. 83, but showing the various components of the device as they appearfollowing delivery to the patient of the fluid contained within thedevice reservoir.

FIG. 85 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 86 is a foreshortened, cross-sectional view taken along lines 86-86of FIG. 85.

FIG. 87 is an exploded, cross-sectional view of the reservoir accessassembly of this latest form of the invention.

FIG. 88 is a foreshortened, longitudinal, cross-sectional view of analternate form of the fluid dispensing device of the invention.

FIG. 89 is a foreshortened longitudinal, cross-sectional view similar toFIG. 88, but showing the various components of the device as they appearfollowing delivery to the patient of the fluid contained within thedevice reservoir.

FIG. 89A is a fragmentary, cross-sectional view of the collapsiblecontainer as it appears in the collapsed configuration.

FIG. 90 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 91 is a cross-sectional view taken along lines 91-91 of FIG. 90.

FIG. 92 is a foreshortened, longitudinal, cross-sectional view of stillanother alternate form of the fluid dispensing device of the invention.

FIG. 93 is a foreshortened longitudinal, cross-sectional view similar toFIG. 92, but showing the various components of the device as they appearfollowing delivery to the patient of the fluid contained within thedevice reservoir.

FIG. 94 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 95 is a foreshortened, cross-sectional view taken along lines 95-95of FIG. 94.

FIG. 96 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 97 is a foreshortened, longitudinal, cross-sectional view ofanother alternate form of the fluid dispensing device of the invention.

FIG. 98 is a foreshortened longitudinal, cross-sectional view similar toFIG. 97, but showing the various components of the device as they appearfollowing delivery to the patient of the fluid contained within thedevice reservoir.

FIG. 99 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 100 is a cross-sectional view taken along lines 100-100 of FIG. 99.

FIG. 101 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 102 is a foreshortened, longitudinal, cross-sectional view of yetanother alternate form of the fluid dispensing device of the invention.

FIG. 103 is a foreshortened longitudinal, cross-sectional view similarto FIG. 102, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 104 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 105 is a foreshortened, cross-sectional view taken along lines105-105 of FIG. 104.

FIG. 106 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 107 is a foreshortened, longitudinal, cross-sectional view of stillanother alternate form of the fluid dispensing device of the invention.

FIG. 108 is a foreshortened longitudinal, cross-sectional view similarto FIG. 107, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 109 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 110 is a cross-sectional view taken along lines 110-110 of FIG.109.

FIG. 111 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 112 is a foreshortened, longitudinal, cross-sectional view of yetanother alternate form of the fluid dispensing device of the invention.

FIG. 113 is a foreshortened longitudinal, cross-sectional view similarto FIG. 112, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 114 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 115 is a foreshortened, cross-sectional view taken along lines115-115 of FIG. 114.

FIG. 116 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 117 is a foreshortened, longitudinal, cross-sectional view of stillanother alternate form of the fluid dispensing device of the invention.

FIG. 118 is a foreshortened longitudinal, cross-sectional view similarto FIG. 117, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 119 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 120 is a cross-sectional view taken along lines 120-120 of FIG.119.

FIG. 121 is a cross-sectional, exploded view of the reservoir accessassembly of this latest form of the invention.

FIG. 122 is a fragmentary, cross-sectional view of the collapsiblecontainer as it appears in the collapsed configuration.

FIG. 123 is a foreshortened, longitudinal, cross-sectional view of yetanother alternate form of the fluid dispensing device of the invention.

FIG. 124 is a foreshortened longitudinal, cross-sectional view similarto FIG. 123, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 125 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 126 is a foreshortened, cross-sectional view taken along lines126-126 of FIG. 125.

FIG. 127 is a cross-sectional view of the Luer-like reservoir accessassembly of this latest form of the invention.

FIG. 128 is a foreshortened, longitudinal, cross-sectional view of stillanother alternate form of the fluid dispensing device of the invention.

FIG. 129 is a foreshortened longitudinal, cross-sectional view similarto FIG. 128, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

FIG. 130 is a top plan view of the collapsible container of thisalternate embodiment of the invention.

FIG. 131 is a cross-sectional view taken along lines 131-131 of FIG.130.

FIG. 132 is a fragmentary, cross-sectional view of the collapsiblecontainer as it appears in the collapsed configuration.

FIG. 133 is a foreshortened, longitudinal, cross-sectional view of stillanother alternate form of the fluid dispensing device of the invention.

FIG. 134 is a foreshortened longitudinal, cross-sectional view similarto FIG. 133, but showing the various components of the device as theyappear following delivery to the patient of the fluid contained withinthe device reservoir.

DESCRIPTION OF THE INVENTION

Definitions: As used herein, the following terms have the followingmeanings:

Unitary Container

A closed container formed from a single component.

Continuous/Uninterrupted Wall.

A wall having no break in uniformity or continuity.

Biologic

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, bloodcomponent or derivative, allergenic product, or analogous productapplicable to the prevention, treatment or cure of diseases or injuriesof the human or animal body.

Hermetically Sealed Container

A container that is designed and intended to be secure against the entryof microorganisms and to maintain the safety and quality of its contentsafter pressurizing.

Drug

As defined by the Food, Drug and Cosmetic Act, drugs are “articles(other than food) intended for the use in the diagnosis, cure,mitigation, treatment, or prevention of disease in man or other animals,or to affect the structure or any function.”

Drug Product

A finished dosage form (e.g. tablet, capsule, or solution) that containsthe active drug ingredient usually combined with inactive ingredients.

Artificial Blood Substitutes

Blood Substitutes are used to fill fluid volume and/or carry oxygen andother gases in the cardiovascular system. These include volume expandersfor inert products, and oxygen therapeutics for oxygen-carryingproducts.

Resuscitation Fluids

Infusion of hyperosmotic-hyperoncotic solutions such as hypertonicsaline dextran (HSD) as used for resuscitation of traumatic shock andperioperative volume support or as an adjunct to other conventionalisotonic crystalloid solutions. Where hypotension is caused bymyocardial depression, pathological vasodilatation and extravascation ofcirculating volume due to widespread capillary leak, a resuscitativeeffort is attempted to correct the absolute and relative hypovolemia byrefilling the vascular tree. Here resuscitation with a small volume ofhypertonic-hyperoncotic solution allows systemic and splanchnichemodynamic and oxygen transport recovery, without an increase inpulmonary artery pressure. Alternate types of normotonic, hyperoncotic,hypertonic, and hypertonic-hyperoncotic solutions can be used forsystemic hemodynamic recovery.

KVO

KVO—keeping-the-vein-open in an IV set up. A phrase that refers to theflow rate of a maintenance IV line established as a prophylactic access.

Nutritionals

Dietary supplemental enteral nutrition support feeding solutions usedfor nasoenteric application typically used in nasogastric, nasoduodenal,nasojejunal, or intravenous routes of administration.

Beneficial Agent

The term beneficial agent can include any substance or compound that isbiologically active and includes any physiologically orpharmacologically active substance that produces a localized or systemiceffect in humans or animals and that can be delivered by the presentinvention to produce a beneficial and useful result.

Diluent

A liquid that which dilutes, as in an inert solution used to dilute amedicament. An inert liquid carrier of a beneficial agent.

Device

An instrument, apparatus, implement, machine, contrivance, implant, invitro reagent, or other similar or related article, including anycomponent, part or accessory, which is intended for use in thediagnosis, cure, treatment or prevention of disease. A device does notachieve its intended purpose through chemical action in the body and isnot dependent upon being metabolized to achieve its purpose.

Apparatus

An appliance or device for a particular purpose: An integrated group ofmaterials or devices used for a particular purpose. The totality ofmeans by which a designated function is performed or a specific taskexecuted, a group of body parts that work together to perform a givenfunction.

Reservoir

A receptacle or chamber for storing a fluid. A part of a machine,device, where liquid is stored.

Liquid Container

A receptacle for holding a liquid. A fluid dispenser that is carried ortransported.

Collapsible

To cause to fold, break down, or fall down or inward or as in bent-overor doubled-up so that one part lies on another.

Collapsible Container

A dispensing device in which one or more walls of the container are madeof a material, which will deform (collapse) when pressure is appliedthereto; or a dispensing device having a collapsible or telescoping wallstructure.

Aseptic Processing

The term ‘aseptic processing’ as it is applied in the pharmaceuticalindustry refers to the assembly of sterilized components and product ina specialized clean environment.

Sterile Product

A sterile product is one that is free from all living organisms, whetherin a vegetative or spore state.

Blow-Fill-Seal Process

The concept of aseptic blow-fill-seal (BFS) is that a container isformed, filled, and sealed as a unitary container in a continuous mannerwithout human intervention in a sterile enclosed area inside a machine.The process is multi-stepped, pharmaceutical grade resin is extrudedinto a tube, which is then formed into a container. A mandrel isinserted into the newly formed container and filled. The container isthen sealed, all inside a sterile shrouded chamber. The product is thendischarged to a non-sterile area for packaging and distribution.

Integrally Formed

An article of one-piece construction, or several parts that are rigidlysecured together and is smoothly continuous in form and that any suchcomponents making up the part have been then rendered inseparable.

Septum

A word borrowed from the Latin “saeptum” meaning a dividing wall orenclosure; thus, a thin partition or membrane that divides two spaces.

Slit Septum

A septum that is partially slit to aid in cannula penetration.

Penetrating

Tending to penetrate; having the power of entering or piercing.

Cutting

Capable of or designed for incising, shearing, or severing as to cut offfrom a main body.

Frangible

An article, item or object that is capable of being ruptured or broken,but does not necessarily imply any inherent materials weakness. Amaterial object, under load that demonstrates a mechanical strain ratedeformation behavior, leading to disintegration.

Luer-Like Connector

A connector used to connect medical devices. Classically, the Luerconsists of a tapered barrel and a conical male part that fits into itwith or without a seal.

Surface Treatment

The processes of surface treatments, more formally surface engineering,to tailor the surfaces of engineering materials to change, alter ormodify the physical surface characteristics and improve the function ofthe materials properties for its intended purpose.

Spring

A mechanical element that can be deformed by a mechanical force suchthat the deformation is directly proportional to the force or torqueapplied to it. An elastic machine component able to deflect under loadin a prescribed manner and to recover its initial shape when unloaded.The combination of force and displacement in a deflected spring isenergy, which may be stored when moving loads are being arrested.

Constant Force Spring

Constant force springs are a special variety of extension spring. Theyare tightly coiled wound bands of pre-hardened spring steel or stainlesssteel strip with built-in curvature so that each turn of the strip wrapstightly on its inner neighbor. When the strip is extended (deflected)the inherent stress resists the loading force, the same as a commonextension spring, but at a nearly constant (zero) rate. Theconstant-force spring is well suited to long extensions with no loadbuild-up. In use, the spring is usually mounted with the ID tightlywrapped on a drum and the free end attached to the loading force.Considerable flexibility is possible with constant-force springs becausethe load capacity can be multiplied by using two or more strips intandem, or back-to-back. Constant force springs are available in a widevariety of sizes.

Referring to the drawings and particularly to FIGS. 1 through 8, oneform of the dispensing device of the present invention for dispensingmedicaments to a patient is there shown and generally designated by thenumeral 50. The dispensing device here includes a supporting structure52, which includes a connector assembly 54 and a generally cylindricallyshaped outer housing 56 that is interconnected with the connectorassembly in the manner best seen in FIG. 4 of the drawings. Supportingstructure 52 can be constructed from metal, plastic or any suitablematerial. Outer housing 56 includes a generally cylindrically shapedwall portion 56 a and a threaded base portion 56 b, the purpose of whichwill presently be described.

Disposed within wall portion 56 a is a carriage assembly 58, which ismovable between a first position shown in FIG. 4 and a second positionshown in FIG. 5. As best seen by referring to FIGS. 4 and 7, carriageassembly 58 comprises a carriage 60 having a carriage base 60 a that isprovided with a plurality of circumferentially spaced openings 62 and agenerally cylindrically shaped sidewall 60 b which terminates in aradially outwardly extending flange 60 c. Carriage assembly 58 isreleasably locked in its first position by a novel locking means thecharacter of which will presently be described.

Carried by carriage assembly 58 is a reservoir defining assembly 64 thatdefines a fluid reservoir 65. As indicated in FIG. 4, reservoir 65 has acombination inlet/outlet 66 that is formed in a shearable reservoirnipple 68 b that comprises a part of the reservoir assembly 64. Nipple68 is connected to an accordion-like member 70 that also comprises apart of the reservoir assembly 64 (FIGS. 4 and 10). Locking teeth 69which circumscribe nipple 68 hold the assembly 64 in place. Reservoirassembly 64 can be constructed from low and high density polyethyleneand polypropylene and like polymers.

In the preferred form of the invention, nipple 68 is sealablyinterconnected with member 70 in accordance with an asepticblow-fill-seal technique. This technique involves the continuousextrusion through an extruder head of a length of parison in the form ofa hollow tube between and through two co-acting first or main moldhalves. The method includes the step of cutting off the parison belowthe extruder head and above the main mold halves to create an openingwhich allows a blowing and filling nozzle assembly to be moveddownwardly into the opening in the parison for molding and thereafterfilling a molded container.

When the container is filled with the desired amount of liquid, theblowing and filling nozzle assembly is retracted from the opening in theparison. A separate pair of co-acting second or upper sealing moldhalves are then moved together around the exposed length of parison toform and seal the container upper portion. The finished container,completely formed, filled, and sealed as a unitary structure is thenconveyed out of the apparatus. Reference should also be made to U.S.Pat. No. 6,145,285 issued to Anderson which discloses an improved methodand apparatus for molding containers using aseptic blow-fill-sealtechniques. Further information concerning aseptic blow-fill-sealtechniques is available from Weiler Engineering of Elgin, Ill.

An important feature of the present invention resides in the provisionof novel guide means for guiding travel of carriage assembly 58 betweenthe first position shown in FIG. 4 and the second position shown in FIG.5. In the present form of the invention this important guide meanscomprises a plurality of circumferentially spaced guide members 74 whichare connected to and extend outwardly from connector 54 b of connectorassembly 54 (FIGS. 4, 6 and 7). As indicated in the drawings, guidemembers 74 are slidably received within openings 62 provided in carriagebase 60 a so that as the carriage assembly travels from its firstposition toward its second position, guide members 74 precisely guideits travel. Also forming a part of the guide means of the apparatus ofthe present invention are a plurality of circumferentially spaced guideribs 76 that are formed on the inner wall of outer housing 56 (FIGS. 6and 7).

To controllably move the carriage assembly from its first position toits second position, novel stored energy means are provided. This novelstored energy means, which is operably associated with carriage assembly58, is here provided in the form of a coiled compression spring 80. Asillustrated in FIGS. 4 and 5, one end 80 a of the coil spring 80 isdisposed in engagement with the threaded base portion 56 b of outerhousing 56 of the supporting structure and the other end 80 b thereof isdisposed in engagement with radially outwardly extending flange 60 c ofcarriage 60. With this construction, when the locking means of theinvention is manipulated in a manner to unlock the carriage assemblyfrom base portion 56 b of the outer housing, spring 80 will move fromits retracted position shown in FIG. 4 to its expanded position shown inFIG. 5, and in so doing will controllably move the carriage assembly 58from its starting position shown in FIG. 4 to its fully deployed, orextended position shown in FIG. 5. As will be described more fully inthe paragraphs which follow, as the carriage assembly moves toward itsdeployed position, the accordion sidewall 70 a of the bellows member 70will move into the collapsed configuration shown in FIG. 5 and in sodoing will cause the medicinal fluid contained within the container tobe controllably substantially expelled therefrom.

To further control the flow of medicinal fluid from reservoir 65 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. This novel fluid flow control means,which is carried by connector assembly 54 of the supporting structure52, here comprises two cooperating components, namely a rate controlmeans for controlling the rate of fluid flow from the collapsiblereservoir and an operating means for controlling fluid flow between thecollapsible reservoir and the rate control means.

Considering first the rate control means of the invention, which isillustrated in FIGS. 31 through 47, this important means comprises arate control housing 84, which includes a generally annular-shapedcavity 84 a (see FIGS. 5 and 32) that closely receives a collar 86formed on connector 54 a of connector assembly 54 (See also FIG. 35). Asbest seen in FIG. 32, rate control housing 84 includes a rate controlcavity 88 and an outwardly extending, shearable nipple 90, the purposeof which will presently be described. Interconnected with a rate controlhousing 84 is a selector member housing 92, that includes a skirt 94that circumscribes rate control housing 84 (FIGS. 4 and 29). Selectormember housing 92 also includes an outwardly extending flange 96 whichdefines a cylindrical space about which the administration line 82 a ofthe administration set can be coiled in the manner best seen in FIG. 4.Additionally, selector member housing 92 is provided with a plurality ofcircumferentially spaced cavities 98 (FIGS. 29 and 30), which areadapted to sealably receive circumferentially spaced-apart outlet ports100 that are formed on rate control cover 102 of the rate controlassembly 104 of the present invention (see FIGS. 36 and 37). In order toensure a positive seal, the outlet ports 100 are provided withelastomeric collars 101 which are sealably received around thecircumferentially spaced-apart outlet ports 100.

As illustrated in FIG. 4, rate control assembly 104, which forms a partof the rate control means of the invention, is closely received withinrate control cavity 88 and is held in position there within by ratecontrol housing 84. In addition to rate control cover 102, rate controlassembly 104 includes a second, mating rate control cover 106 and anovel rate control plate 110 (FIG. 42) that is disposed between covers102 and 106. As will presently be described, rate control plate 110 canbe constructed from a variety of plastic materials and is provided witha plurality of fluid flow channels 112 of different lengths, widths,depths and geometry that are in fluid communication with outlet 66 ofcollapsible reservoir 65.

As previously discussed, the rate control means of the inventionincludes selector means for selecting the rate of fluid flow betweencollapsible reservoir 65 and the administration set 82 of the invention.In addition to the previously identified selector member housing 92, theselector means includes a selector member 116 that is held in positionby a retainer member 159, and is rotatably carried by the selectorhousing (FIG. 4). A plurality of O-rings 117, which circumscribe thebody portion of selector member 116, provide a substantially leak-tightseal between the components. Selector member 116 carries a pierceabledrug recovery septum 119, which forms a part of the recapture means ofthe invention and includes an axially extending fluid passageway 116 a,that provides fluid communication between septum 119 and the fluidreservoir via rate control assembly 104 and frangible nipple 90. As willbe discussed in the paragraphs which follow, selector member 116 is alsoprovided with a plurality of circumferentially extending passagewaysthat communicate with the rate control passageways formed in ratecontrol plate 110 via fluid passageways formed in selector memberhousing 92 (see FIG. 47A).

Considering next the previously identified operating means of theinvention, which is illustrated in FIGS. 12 through 20, this importantoperating means, which controls fluid flow between collapsible reservoir64 and the rate control means, here comprises an operating shaft 122that is rotatably mounted within a generally cylindrically shapedchamber 124 formed in connector 54 of supporting structure 52. Operatingshaft 122 can be rotated within chamber 124, which is closed by a cap124 a, by an “L”-shaped operating handle 126 (FIG. 3) between a firstposition shown in FIG. 18 blocking fluid flow from collapsible reservoir64 toward administration set 82 and a second position shown in FIG. 20permitting fluid flow from the reservoir toward the administration set.

Turning particularly to FIGS. 12 and 15, operating shaft 122 can be seento comprise a body portion 122 a and a reduced diameter neck portion 122b. Circumferentially spaced-apart, generally arcuate-shaped cavities 130and 132, which are formed in body portion 122 a, are strategicallylocated to receive the end portions of nipples 68 and 90 when theoperating shaft is in held in position within chamber 124 by retainerclips 125 in the manner shown in FIG. 4. Also formed within operatingshaft 122 is a transversely extending fluid passageway 134, which, uponrotation of the operating shaft by handle 126, can be moved intoalignment with the fluid passageways 68 a and 90 a of nipples 68 and 90respectively (see FIG. 20).

Mounted within each of the cavities 130 and 132 is a spring knife 136which, as indicated in FIGS. 16 and 17, includes a cutting edge 136 aformed proximate one extremity and a pair of mounting clips 137 providedproximate the opposite extremity. Tabs 137 a of the mounting clips arereceived within slots 139 formed in body portion 122 a so as to securethe spring knives within the arcuate cavities in the manner illustratedin FIG. 15. With this construction, as the operating shaft 122 isrotated by handle 126 from the position shown in FIG. 18 into theposition shown in FIG. 19 the spring knives will cleanly sever thesealed tip portions 68 b and 90 b of the frangible, shearable nipples 68and 90 respectively. Continued rotation of operating member 122 willmove sealed tip portions 68 b and 90 b into the cavities for rotationtherewith (FIG. 19) and will move transverse passageway 134 intoalignment with passageways 68 a and 90 a in a manner shown in FIG. 20.With the operating member in this position fluid can flow freely fromreservoir 65 toward the rate control means of the invention viapassageways 68 a and 90 a of nipples 68 and 90.

From passageway 90 a fluid will flow through a conventional particulatefilter 139, into inlet 140 of rate control cover 106 of the rate controlassembly 104, into inlet 141 of rate control plate 110 and then into thevarious circuitous fluid channels 112 a, 112 b, 112 c, 112 d, 112 e and112 f formed in the rate control plate, each of which may be of adifferent length, width, depth and geometry (see FIGS. 42 and 47A). Aseach of the channels fills with the medicinal fluid to be dispensed tothe patient, the fluid will flow into outlet passageways 100 a, 100 b,100 c, 100 d, 100 e and 100 f respectively formed in rate control cover102. From these outlet passageways, the fluid flows into and fillscircumferentially spaced-apart fluid passageways 144 a, 144 b, 144 c,144 d, 144 e and 144 f formed in selector housing 92 (see FIG. 30).

As best seen by referring to FIG. 24, selector member 116 is providedwith an inlet passageway 146 and an outlet passageway 148 that isinterconnected with inlet passageway 146 by means of an axiallyextending stub passageway 150 which, in turn, is connected to acircumferentially extending passageway 151 formed in selector member 116(FIG. 47A). With this construction, by rotating the selector member 116,inlet passageway 146 can be selectively brought into index with one ofthe radial extensions 147 of the axially extending passageways formed inselector member 92 thereby providing fluid communication between outletpassageway 148 and the selected one of the circuitous flow passagewaysformed in rate control plate 110 via annular passageway 151 and theselected axially extending passageway formed in the selector housing 92.Since outlet passageway 148 is in fluid communication with theadministration set 82 of the invention via passageway 151, the rate offluid flow toward the patient can be precisely controlled by selecting arate control passageway of appropriate length that is formed in ratecontrol plate 110.

With the device in the configuration shown in FIGS. 1, 2 and 4, and withthe fluid reservoir 65 filled with the medicament to be dispensed to thepatient, the dispensing operation can be commenced by removing the topcover 153, which is snapped over a cover connector 155 that protrudesfrom the structural member 54 a. With the cover removed, theadministration line 82 a of the administration set 82 can be unwrappedfrom the selector member housing about which it has been coiled (seeFIGS. 3 and 4). Removal of the top cover 153 also exposes the selectormember 116 so that the fluid flow rate can be selected by actioning theinterlock 116 r and rotating the selector member to the desired flowrate indicated by the indicia 157 imprinted on the selector membercomponent 116. With the desired flow rate thusly set, the operatingshaft 122 is next rotated through the use of the operating handle 126from the starting position shown in FIG. 18 to the fully rotatedposition shown in FIG. 20. In this way, communication is opened betweenthe reservoir outlet 66 and passageway 90 a of nipple 90 which, in turn,is in communication with the rate control assembly of the invention.

Following the controlled rotation of the operating shaft 122, which isinterconnected with structural member 54 a, the carriage locking meansof the invention can be manipulated in a manner to release the carriage60 from base member 56 b in order to permit the stored energy means, orspring 80, to move the carriage from the starting position shown in FIG.4 to the extended position shown in FIG. 5. In this regard, as best seenin FIGS. 53 and 55, the carriage locking means includes a locking member164 having a shank portion 164 a which extends through a keyhole-shapedopening 162 provided in the carriage base (see FIG. 48) and a generallykeyhole-shaped locking portion 164 b. The carriage locking means alsoincludes a finger-engaging, operating member 166 that includes a drivingrib 166 a that is received within a groove formed within shaft 164 a.Operating member 166 functions to rotate locking member 164 from atransverse locking position to a release position in alignment withkeyhole opening 162 formed in carriage base 60 d. As indicated in FIGS.51 and 52 base 56 b of the supporting structure is provided withcircumferentially spaced-apart indexing buttons 168 which are receivedwithin a button receiving cavity 166 b formed in finger-engaging member166 as the operating member is rotated from a locked position to arelease position (FIG. 53). As shown in FIG. 52, to assist the caregiverin performing the carriage release step, base 56 b is provided withindicia 169 indicating the locking and release position of the operatingmember 166.

Following the release of the carriage assembly, the stored energy means,or coiled spring 80, will move the carriage from a position shown inFIG. 4 into the position shown in FIG. 5 and in so doing will urge thefluid contained within reservoir 65 to flow toward reservoir outlet 66,into passageway 134 formed in control member 122 and into passageway 90a of nipple 90. From passageway 90 a, fluid will flow into inlet 140 ofrate control cover 106 of the rate of control assembly 104, into inlet141 of rate control plate 110 and then into the various circuitous fluidchannels 112 a, 112 b, 112 c, 112 d, 112 e and 112 f formed in the ratecontrol plate. As each of the channels fills with the medicinal fluid tobe dispensed to the patient, the fluid will flow into outlet passageways100 a, 100 b, 100 c, 100 d, 100 e and 100 f respectively formed in ratecontrol cover 102. From these outlet passageways, the fluid will flowinto and fill the circumferentially spaced-apart fluid passageways 144a, 144 b, 144 c, 144 d, 144 e and 144 f formed in selector housing 92(see FIG. 30).

As previously discussed, by rotating the selector member 116, inletpassageway 146 of selector member 116 can be selectively brought intoindex with one of the radial extensions 147 of the passageways formed inselector member housing 92 thereby providing fluid communication betweenoutlet passageway 148 and the selected one of the circuitous flowpassageways 112 (see FIGS. 24 and 29) formed in rate control plate 110.Since outlet passageway 148 is in fluid communication with theadministration set 82 of the invention via passageway 151, the rate offluid flow toward the patient can be precisely controlled by selecting arate control passageway of appropriate length that is formed in ratecontrol plate 110 (see FIG. 47A).

In the present form of the invention, administration set 82, whichcomprises a part of the dispensing means of the invention for deliveringmedicinal fluids to the patient, includes, in addition to administrationline 82 a, a conventional “Y”-site injection septum or port 172, aconventional gas vent and particulate filter 174 and a line clamp 176.Provided at the distal end of the administration line is a luerconnector 178 of conventional construction (FIG. 3) which enables thedevice to be interconnected with the patient in a conventional manner.

In those special instances where reservoir 65 has not been filled withthe medicament at the time of manufacture, the reservoir can beexpeditiously filled in the field by a relatively simple procedure. Moreparticularly, after rotating the control shaft in the manner previouslydescribed and to sever the sealed tip portions of the nipples 70 and 90,the medicament to be delivered to the patient can be transferred from aconventional syringe or the like to reservoir 65 via pierceable drugrecovery septum 119, fluid passageway 116 a, rate control assembly 104and passageways 90 a and 70 a of nipples 90 and 70 (see FIGS. 5 and47A).

Using a conventional syringe, or like device, pierceable septum 119 canalso be used to recover any medicament that may remain in reservoir 65following the fluid delivery step.

Turning now to FIGS. 56 through 62, an alternate form of the dispensingdevice of the present invention for dispensing medicaments to a patientis there shown and generally designated by the numeral 200. Thisalternate form of dispensing device is similar in many respects to thatshown in FIGS. 1 through 55 and like numerals are used in FIGS. 56through 62 to identify like components. As before, the dispensing devicehere includes a supporting structure 52 which includes a connectorassembly 54 and a generally cylindrically shaped outer housing 56 thatis interconnected with the connector assembly in the manner best seen inFIG. 56 of the drawings.

Disposed within wall portion 56 a is a carriage assembly 58 which ismovable between a first position shown in FIG. 56 and a second positionshown in FIG. 57. Carriage assembly 58 is of identical construction andoperation to that previously described and is releasably locked in itsfirst position by locking means also identical to the locking meanspreviously described herein.

The primary difference between this latest form of dispensing device ofthe invention and that previously described resides in the provision ofa reservoir defining assembly 202 of a totally different construction.Reservoir defining assembly 202 here comprises a collapsible containerassembly 204 which is carried by carriage assembly 58 in the mannerillustrated in FIG. 56.

As best seen by referring to FIGS. 58 through 61, collapsible containerassembly 204 includes a collapsible, telescoping sidewall 204 a, aninterconnected bottom wall 204 b and an interconnected top wall 204 c towhich a sealed reservoir nipple 206 is integrally formed and sealablyinterconnected. Collapsible container assembly 204 defines a fluidreservoir 207 having an inlet/outlet that is generally identified by thenumeral 208.

In the preferred form of this alternate embodiment of the invention,shearable nipple 206 is integrally formed and sealably interconnectedwith member top wall 204 c in accordance with an aseptic blow-fill-sealtechnique of the general character previously described to form aunitary structure.

As in the earlier described embodiment of the invention, an importantfeature of this latest form of the invention resides in the provision ofnovel guide means for guiding travel of carriage assembly 58 between thefirst position shown in FIG. 56 and the second position shown in FIG.57. This important guide means is of identical construction andoperation to that previously described herein.

To controllably move the carriage assembly from its first position toits second position, novel stored energy means are provided. This novelstored energy means, which is operably associated with carriage assembly58, is here provided in the form of a coiled spring 80 which is alsoidentical in construction and operation to that previously described.

As in the earlier described embodiment of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 56 b of the outer housing, spring 80will move from its compressed position shown in FIG. 56 to its expandedposition shown in FIG. 57 and in so doing will controllably move thecarriage assembly from its starting position shown in FIG. 56 to itsfully deployed, or extended, position shown in FIG. 57. As the carriageassembly moves toward its deployed position, the collapsible sidewall204 a of the collapsible container 204 will move into the collapsedconfiguration shown in FIGS. 57 and 60. As the collapsible containercollapses, the sidewalls will telescope and the medicinal fluidcontained within the container will be controllably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 207 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. This novel fluid flow control means,which is identical in construction and operation to that previouslydescribed, comprises two cooperating components, namely a rate controlmeans for controlling the rate of fluid flow from the collapsiblereservoir and an operating means for controlling fluid flow between thecollapsible reservoir and the rate control means. These importantcomponents are fully described in the preceding paragraphs.

As in the earlier described embodiment of the invention, the importantoperating means, which controls fluid flow between collapsible reservoir207 and the rate control means, here comprises an operating shaft 122that is rotatably mounted within a generally cylindrically shapedchamber 124 formed in connector 54 a of supporting structure 52. Asbefore, operating shaft 122 can be rotated within chamber 124 by an“L”-shaped operating handle 126 between a first position blocking fluidflow from collapsible reservoir 207 toward administration set 82 and asecond position permitting fluid flow from the reservoir toward theadministration set.

As illustrated in FIG. 56, operating shaft 122 includes a body portion122 a and a reduced diameter neck portion 122 b. Circumferentiallyspaced-apart generally arcuate-shaped cavities 130 and 132, which areformed in body portion 122 a, are strategically located to receive theend portions of nipples 206 and 90 when the operating shaft is in heldin position within chamber 124 by retainer clips 125 in the manner shownin FIG. 56. Also formed within operating shaft 122 is a transverselyextending fluid passageway 134 which, upon rotation of the operatingshaft by handle 126, can be moved into alignment with the fluidpassageways 206 a and 90 a of nipples 206 and 90 respectively.

Mounted within each of the cavities 130 and 132 is a spring knife 136,which includes a cutting edge formed proximate one extremity and a pairof mounting clips provided proximate the opposite extremity. As theoperating shaft 122 is rotated by the operating handle 126 from it firstposition into its second position the spring knives will cleanly severor shear the sealed tip portions 206 b and 90 b of nipples 206 and 90respectively. Continued rotation of operating member will move sealedtip portions 206 b and 90 b into the cavities for rotation therewith andwill move transverse passageway 134 into alignment with passageways 206a and 90 a. With the operating member in this position fluid can flowfreely from reservoir 207 toward the rate control means of the inventionvia passageways 206 a and 90 a of nipples 206 and 90.

From passageway 206 a, fluid will flow through a conventionalparticulate filter 139, into inlet 140 of rate control cover 106 of therate of control assembly 104, into inlet 141 of rate control plate 110and then into the various circuitous fluid channels of the rate controlplate in the manner previously described. The fluid will then flow intothe circumferentially spaced-apart fluid passageways formed in theselector housing 92 via rate control cover 102. In operating the devicein the manner previously described herein, by rotating the selectormember 116, inlet passageway 146 can be selectively brought into indexwith one of the radial extensions 147 of the axially extendingpassageways formed in selector member 92, thereby providing fluidcommunication between outlet passageway 148 and the selected one of thecircuitous flow passageways formed in rate control plate 110 via annularpassageway 151 and the selected axially extending passageway formed inthe selector member housing 92. Since outlet passageway 148 is in fluidcommunication with the administration set 82 of the invention via theannular grove and passageway 151, the rate of fluid flow toward thepatient can be precisely controlled by selecting a rate controlpassageway of appropriate length, width, depth and geometry that isformed in rate control plate 110.

As before, by using a conventional syringe, or like device, pierceableelastomeric septum 119 can be used to recover any medicament that mayremain in reservoir 207 following the fluid delivery step.

Referring next to FIGS. 63 through 76, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 212.This alternate form of dispensing device is similar in some respects tothat shown in FIGS. 56 through 62 and like numerals are used in FIGS. 63through 75 to identify like components. Because the flow control meansof this latest form of the invention is of different construction andoperates in a different way, the dispensing device 212 includes asupporting structure 214, which, is of necessity, somewhat different inconstruction. More particularly, the supporting structure 214 herecomprises a connector assembly 216 and a generally cylindrically shapedouter housing 218 that is interconnected with the connector assembly inthe manner best seen in FIG. 63 of the drawings.

Disposed within outer housing 218 is the carriage assembly 58, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly 58 is a reservoirdefining assembly 222, which is of similar construction to reservoirassembly 204 and here includes a collapsible container assembly 224 madefrom a blow-fill process (as distinguished from a blow-fill-sealprocess) having a sidewall 224 a, an interconnected bottom wall 224 band an interconnected top wall 224 c to which the accessing means of theinvention for accessing the reservoir of the container assembly. Thisnovel accessing means is here shown as a sealed reservoir insert septumassembly 226 is sealably interconnected (see FIG. 67). Collapsiblecontainer assembly 224 defines a fluid reservoir 227 that, in a mannerpresently to be described, is accessible via a slit septum 230, whichhas been insert-molded and comprises a part of reservoir sealing meansor septum assembly 226. As best seen in FIG. 67, septum 230 is disposedwithin a generally cylindrically shaped holding ring 232, which, inturn, is disposed within a housing 234 that is sealably interconnectedwith top wall 224 c.

In the preferred form of this alternate embodiment of the invention,reservoir septum assembly 226 is sealably interconnected with top wall224 c in accordance with the previously described aseptic blow-fill-sealtechnique.

The primary difference between this latest form of dispensing device ofthe invention and those previously described herein resides in theprovision of a totally different operating means for controlling fluidflow between the collapsible reservoir 224 and the rate control means.

As in the earlier described embodiments of the invention, novel guidemeans are provided for guiding travel of carriage assembly 58 betweenthe first position shown in FIG. 63 and the second position shown inFIG. 64. This important guide means is of identical construction andoperation to that previously described herein.

Once again, in order to controllably move the carriage assembly from itsfirst position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 58, is here provided in the form of a coiledcompression spring 80, which is also of identical construction andoperation to that previously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 218 a of the outer housing 218,spring 80 will move from its retracted position shown in FIG. 63 to itsexpanded position shown in FIG. 64 and in so doing will controllablymove the carriage assembly from its starting position shown in FIG. 63to its fully deployed or extended position shown in FIG. 64. As thecarriage assembly moves toward its deployed position, the collapsiblesidewall 224 a of the collapsible container 224 will move into thecollapsed configuration shown in FIGS. 64 and 69. As the walls of thecollapsible container telescopically collapse, the medicinal fluidcontained within the container will be controllably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 227 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. Once again, this novel fluid flowcontrol means, comprises two cooperating components, namely a ratecontrol means for controlling the rate of fluid flow from thecollapsible reservoir and an operating means for controlling fluid flowbetween the collapsible reservoir and the rate control means. Aspreviously mentioned, the operating means of this latest form of theinvention is a different construction and operation from the previouslydescribed operating means. However, the rate control means of thislatest form of the invention is similar in construction to thatpreviously described and the rate control assembly of the rate controlmeans is identical in construction and operation to that previouslydescribed.

The important operating means of this latest embodiment of theinvention, which controls fluid flow between reservoir 227 and the ratecontrol means, here comprises a septum penetrating assembly generallydesignated by the numeral 238 (See FIGS. 72 through 74). Assembly 238,which is disposed within a skirt 240 formed on selector member housing242, includes internal threads 238 t which threadably mate with externalthreads 216 t. Assembly 238 also includes a septum penetrating member244 which is received within a guide passageway 246 formed on supportmember 216 (FIG. 63). Assembly 238 also includes a cavity 238 a, whichclosely receives a portion of the rate control assembly 104.

In this latest embodiment of the invention, selector member housing 242,along with septum penetrating assembly 238 is movable within a guidesleeve 250 that extends outwardly from support member 216, from thefirst position shown in FIG. 63 to the second position shown in FIG. 64.In addition to guiding the travel of the septum penetrating assembly,guide sleeve 250 defines a cylindrical space 250 a about which theadministration line 82 a of the administration set 82 can be coiled inthe manner best seen in FIG. 63.

Selector member housing 242 is retained in its first position by a tearstrip 252 that is removably receivable between a circumferentiallyextending rib 242 a formed on housing 242 and the upper extremity 250 bof guide sleeve 250. When the tear strip 252 is removed in the mannerillustrated in FIG. 76, a rotary force exerted on selector memberhousing 242 will cause the cooperative engagement of the mating threads238 t and 216 t to move the housing along with the septum penetratingassembly into the second position shown in FIG. 64 and in so doing willcause the septum penetrating member 244 to pierce the septum in themanner shown in FIG. 64. Piercing of the septum 230 opens a fluidcommunication path from reservoir 227 to the rate control assembly 104via a central fluid passageway 244 a formed in septum penetrating member244. From passageway 244 a, fluid will flow through conventionalparticulate filter 139, into inlet 140 of rate control cover 106 of therate of control assembly 104, into inlet 141 of rate control plate 110and then into the various circuitous fluid channels of the rate controlplate in the manner previously described. The fluid will then flow intothe circumferentially spaced-apart fluid passageways formed in theselector housing 242. In operating the device in the manner previouslydescribed herein, by rotating the selector member 116, which is carriedby selector member housing 242, inlet passageway 144 a can beselectively brought into index with one of the radial extensions 147 ofthe axially extending passageways formed in selector member 242, therebyproviding fluid communication between outlet passageway 148 and theselected one of the circuitous flow passageways formed in rate controlplate 110 via annular passageway 151 and the selected axially extendingpassageway formed in the selector member 242. Since outlet passageway148 is in fluid communication with the administration set 82 of theinvention via passageway 151, the rate of fluid flow toward the patientcan be precisely controlled by selecting a rate control passageway ofappropriate length, width, depth and geometry that is formed in ratecontrol plate 110.

As previously described, by using a conventional syringe, or likedevice, pierceable elastomeric drug recovery septum 119 can be used torecover any medicament that may remain in reservoir 227 following thefluid delivery step.

Turning next to FIGS. 77 through 82, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 262.This alternate form of dispensing device is similar in some respects tothat shown in FIGS. 63 through 76 and like numerals are used in FIGS. 77through 82 to identify like components. As best seen in FIGS. 77 and 78the supporting structure 264 is similar in many respects to supportingstructure 214 and here comprises a connector assembly 266 and agenerally cylindrically shaped outer housing 268 that is interconnectedwith the connector assembly in the manner best seen in FIG. 77 of thedrawings.

Disposed within outer housing 268 is the carriage assembly 58, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly 58 is a reservoirdefining assembly 270, which is of a somewhat different construction.This important reservoir defining assembly here includes an integrallyformed collapsible container assembly 272 having a continuous wallincluding a sidewall 272 a, an interconnected bottom wall 272 b, aninterconnected top wall 272 c and an interconnected neck portion 272 dwhich is sealed at the time of manufacture by a thin pierceable closurewall 274. Neck portion 272 d, which is preferably integrally formed withtop wall 272 c, forms a part of the novel reservoir access means of theinvention. The collapsible container of container assembly 272 comprisesa unitary structure that defines a fluid reservoir 277 that, in a mannerpresently to be described, is accessible via a penetrating member 280that is adapted to pierce thin closure wall 274 as well as a pierceablemembrane 282 which is positioned over closure wall 274 by means of aclosure cap 284 which is affixed to the neck portion 272 d of containerassembly 272 (see FIGS. 80 and 81). Penetrating member 280, pierceablemembrane 282 and closure cap 284 also form a part of the novel reservoiraccess means of the invention. Container assembly 272 can beinterconnected with connector member 266 as a snapfit by a threadedconstruction or any other convenient mechanism.

In the preferred form of this latest alternate embodiment of theinvention, closure wall 274 is sealably interconnected with neck portion272 d in accordance with the previously described aseptic blow-fill-sealtechnique.

The primary difference between this latest form of dispensing device ofthe invention and those previously described herein resides in thesomewhat differently configured container assembly 272 and the somewhatdifferently configured penetrating member 280. In constructing thecontainer assembly 272, the basic container is formed using the asepticblow-fill-seal technique earlier described herein and the reservoirportion of the container is sealed by reservoir accessing means whichcomprises the thin closure wall 274. The piercable membrane 282 is thenpositioned over the closure wall 274 and the cap 284 is positioned overthe piercable membrane and secured to neck portion 272 d by any suitablemeans such as adhesive bonding or sonic welding. Membrane 282, cap 284and neck portion 272 d all comprise a part of the reservoir accessingmeans of this latest form of the invention. It is important to note thatclosure wall 274 effectively prevents the medicament contained withinthe fluid reservoir from coming in contact with the membrane 282 at anytime prior to accessing the reservoir.

As in the earlier described embodiments of the invention, novel guidemeans are provided for guiding travel of carriage assembly 58 betweenthe first position shown in FIG. 77 and the second position shown inFIG. 78. This important guide means is of identical construction andoperation to that previously described herein.

Once again, in order to controllably move the carriage assembly from itsfirst position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 58, is here provided in the form of a coiledspring 80, which is also identical in construction and operation to thatpreviously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 268 a of the outer housing 268,spring 80 will move from its retracted position shown in FIG. 77 to itsexpanded position shown in FIG. 78 and in so doing will controllablymove the carriage assembly from its starting position shown in FIG. 77to its fully deployed or extended position shown in FIG. 78. As thecarriage assembly moves toward its deployed position, the collapsiblesidewall 272 a of the collapsible container 272 will move into thecollapsed configuration shown in FIGS. 78 and 82. As the collapsiblecontainer collapses, the medicinal fluid contained within the containerwill be controllably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 277 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. Once again, this novel fluid flowcontrol means, comprises two cooperating components, namely a ratecontrol means for controlling the rate of fluid flow from thecollapsible reservoir and an operating means for controlling fluid flowbetween the collapsible reservoir and the rate control means. Aspreviously mentioned, the operating means of this latest form of theinvention is of a different construction and operation from thepreviously described operating means. However, the rate control means ofthis latest form of the invention is similar in construction to thatpreviously described and the rate control assembly of the rate controlmeans is identical in construction and operation to that previouslydescribed in connection with Figure drawings 36 through 74A.

The important operating means of this latest embodiment of theinvention, which controls fluid flow between collapsible reservoir 277and the rate control means, here comprises a penetrating assemblygenerally designated by the numeral 288 (See FIGS. 77 and 78). Assembly288, which is disposed within a skirt 240 formed on a selector memberhousing 242, includes the previously identified penetrating member 280which is sealably received within a guide passageway 290 formed onsupport member 266 (FIG. 77). Assembly 288 also includes a cavity 288 a,which closely receives a portion of the rate control assembly 104.

In this latest embodiment of the invention, selector member housing 242,along with septum penetrating assembly 288 is movable within a guidesleeve 250 that extends outwardly from support member 266, from thefirst position shown in FIG. 77 to the second position shown in FIG. 78.In addition to guiding the travel of the penetrating assembly, guidesleeve 250 defines a cylindrical space 252 a about which theadministration line 82 a of the administration set 82 can be coiled inthe manner best seen in FIG. 77.

As in the earlier described embodiment, selector member housing 242 isretained in its first position by a tear strip 252 that is removablyreceivable between a circumferentially extending rib 242 a formed onhousing 242 and the upper extremity 250 b of guide sleeve 250. When thetear strip 252 is removed, a rotary force exerted on selector memberhousing 242 will move the housing along with the penetrating assemblyinto the second position shown in FIG. 78 and in so doing will cause thepenetrating member 280 to pierce the membrane 282 as well as the closurewall 274 in the manner shown in FIG. 78. Piercing of the membrane 282and the closure wall 274 opens a fluid communication path from reservoir277 to the rate control assembly 104 via a central fluid passageway 280a formed in penetrating member 280. From passageway 280 a, fluid willflow through conventional particulate filter 139, into inlet 140 of ratecontrol cover 106 of the rate of control assembly 104, into inlet 141 ofrate control plate 110 and then into the various circuitous fluidchannels of the rate control plate in the manner previously described.The fluid will then flow into the circumferentially spaced-apart fluidpassageways formed in the selector housing 242. In operating the devicein the manner previously described herein, by rotating the selectormember 116, which is carried by selector member housing 242, inletpassageway 144 a can be selectively brought into index with one of theradial extensions 147 of the axially extending passageways formed inselector member 242, thereby providing fluid communication betweenoutlet passageway 148 and the selected one of the circuitous flowpassageways formed in rate control plate 110 via annular passageway 151and the selected axially extending passageway formed in the selectormember 242. Since outlet passageway 148 is in fluid communication withthe administration set 82 of the invention via passageway 151, the rateof fluid flow toward the patient can be precisely controlled byselecting a rate control passageway of appropriate length, width andgeometry that is formed in rate control plate 110.

Referring to FIGS. 83 through 87, yet another form of the dispensingdevice of the present invention for dispensing medicaments to a patientis there shown and generally designated by the numeral 302. Thisalternate form of dispensing device is similar in most respects to thatshown in FIGS. 77 through 82 and like numerals are used in FIGS. 83through 87 to identify like components. The major difference betweenthis latest embodiment of the invention and that shown in FIGS. 77through 82 resides in the differently configured reservoir definingcontainer 304. As shown in FIG. 85 container 304, rather than being inthe nature of the collapsible bottle, comprises a reservoir definingcontainer formed as a unitary structure having a bellows-like sidewall304 a that is movable from the expanded, starting configuration shown inFIG. 83 to the collapsed configuration shown in FIG. 84. This importantreservoir defining container here includes, in addition to sidewall 304a, an interconnected bottom wall 304 b, an interconnected top wall 304 cand an interconnected neck portion 304 d which is sealed at the time ofmanufacture by an integrally formed, thin closure wall 305. Neck portion304 d, which is preferably integrally formed with top wall 304 c, formsa part of the novel reservoir access means of the invention. Collapsiblecontainer 304 defines a fluid reservoir 307 that, in a manner presentlyto be described, is accessible via a penetrating member 280 that isadapted to pierce closure wall 305 as well as a pierceable membrane 306which is positioned over closure wall 305 of by means of a closure cap309 which is affixed to the neck portion 304 d of container assembly 304(see also FIG. 87).

As best seen in FIGS. 83 and 84 the supporting structure 264 issubstantially identical to the supporting structure of the lastdescribed embodiment and here comprises a connector assembly 266 and agenerally cylindrically shaped outer housing 268 that is interconnectedwith the connector assembly in the manner best seen in FIG. 83 of thedrawings.

Disposed within outer housing 268 is the carriage assembly 58, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly 58 is the previouslydescribed reservoir defining container 304.

As in the last described embodiment of the invention, closure wall 305is sealably interconnected with neck portion 304 d in accordance withthe previously described aseptic blow-fill-seal technique. As in thelast described embodiment of the invention, the basic container 304 isformed using the earlier described aseptic blow-fill-seal technique andthe reservoir portion of the container is sealed by the thin closurewall 305. The piercable membrane 306 is then positioned over the closurewall 305 and the cap 309 is positioned over the piercable membrane andsecured to the integrally formed neck portion 304 d by any suitablemeans such as adhesive bonding or sonic welding.

As before, novel guide means are provided for guiding travel of carriageassembly 58 between the first position shown in FIG. 83 and the secondposition shown in FIG. 84. This important guide means is of identicalconstruction and operation to that previously described herein.

Once again, in order to controllably move the carriage assembly from itsfirst position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 58, is here provided in the form of a coiledspring 80, which is also identical in construction and operation to thatpreviously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 268 a of the outer housing 268,spring 80 will move from its compressed position shown in FIG. 83 to itsexpanded position shown in FIG. 84 and in so doing will controllablymove the carriage assembly from its starting position shown in FIG. 83to its fully deployed or extended position shown in FIG. 84. As thecarriage assembly moves toward its deployed position, theaccordion-like, collapsible sidewall 304 a of the collapsible container304 will move into the collapsed configuration shown in FIG. 84. As thecontainer collapses, the medicinal fluid contained within the containerwill be controllably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 307 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. These important flow control means areidentical to those previously described in connection with theembodiment of FIGS. 77 through 82 and will not here be furtherdiscussed.

As in the last described embodiment, selector member housing 242 isretained in its first position by a tear strip 252 that is removablyreceivable between a circumferentially extending rib 242 a formed onhousing 242 and the upper extremity 250 b of guide sleeve 250. When thetear strip 252 is removed, a rotary force exerted on selector memberhousing 242 will move the housing along with the penetrating assemblyinto the second position shown in FIG. 84 and in so doing will cause thepenetrating member 280 to pierce the membrane 306 as well as the closurewall 305. Piercing of the membrane 306 and the closure wall 305 opens afluid communication path from reservoir 307 to the rate control assembly104 via a central fluid passageway 280 a formed in septum penetratingmember 280. From passageway 280 a, fluid will flow through conventionalparticulate filter 139, into inlet 140 of rate control cover 106 of therate of control assembly 104, into inlet 141 of rate control plate 110and then into the various circuitous fluid channels of the rate controlplate in the manner previously described. The fluid will then flow intothe circumferentially spaced-apart fluid passageways formed in theselector housing 242. In operating the device in the manner previouslydescribed herein, by rotating the selector member 116, which is carriedby selector member housing 242, inlet passageway 144 a can beselectively brought into index with one of the radial extensions 147 ofthe axially extending passageways formed in selector member 242, therebyproviding fluid communication between outlet passageway 148 and theselected one of the circuitous flow passageways formed in rate controlplate 110 via annular passageway 151 and the selected axially extendingpassageway formed in the selector member 242. Since outlet passageway148 is in fluid communication with the administration set 82 of theinvention via passageway 151, the rate of fluid flow toward the patientcan be precisely controlled by selecting a rate control passageway ofappropriate length that is formed in rate control plate 110.

Turning next to FIGS. 88 through 91, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 312.This alternate form of dispensing device is similar in many respects tothat shown in FIGS. 83 through 87 and like numerals are used in FIGS. 88through 91 to identify like components. As best seen in FIGS. 88 and 89the supporting structure 314 is similar in many respects to supportingstructure 214 and here comprises a connector assembly 316 and agenerally cylindrically shaped outer housing 318 that is interconnectedwith the connector assembly in the manner best seen in FIG. 88 of thedrawings.

Disposed within outer housing 318 is the carriage assembly 58, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly 58 is a reservoirdefining assembly 320, which is of a somewhat different construction.This important reservoir defining assembly here includes a collapsiblecontainer assembly 322 having a sidewall 322 a, an interconnected bottomwall 322 b and an interconnected top wall 322 c. Connected to top wall322 c and extending therefrom is a Luer-like connector 324 havingexternal threads 324 a and a sealing wall 324 b. Connector 324, which isinterconnected with top wall 322 c is integrally formed and sealablyinterconnected at the time of manufacture of the collapsible containerassembly 322, forms a part of the novel reservoir access means of thislatest form of the invention. Collapsible container assembly 322 definesa fluid reservoir 327 that, in a manner presently to be described, isaccessible via a slightly differently configured penetrating member 330that is adapted to pierce top sealing wall 322 s and sealably engagetapered sealing wall 324 b (FIGS. 88 and 91).

In the preferred form of this latest alternate embodiment of theinvention, Luer-like connector 324 is sealably interconnected with topwall 322 c in accordance with the previously described asepticblow-fill-seal technique.

As previously mentioned, the primary differences between this latestform of dispensing device of the invention and those previouslydescribed herein resides in the somewhat differently configuredcontainer assembly 322 and the somewhat differently configuredpenetrating member 330. In constructing the container assembly 322, thebasic container is formed as a unitary structure using the asepticblow-fill-seal technique earlier described herein and the reservoirportion of the container is sealed by the interconnected walls of thecontainer and integral sealing wall 322 s.

As in the earlier described embodiments of the invention, novel guidemeans are provided for guiding travel of carriage assembly 58 betweenthe first position shown in FIG. 88 and the second position shown inFIG. 89. This important guide means is of identical construction andoperation to that previously described herein.

Once again, in order to controllably move the carriage assembly from itsfirst position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 58, is here provided in the form of a coiledspring 80, which is also identical in construction and operation to thatpreviously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 318 b of the outer housing 318,spring 80 will move from its retracted position shown in FIG. 88 to itsexpanded position shown in FIG. 89 and in so doing will controllablymove the carriage assembly from its starting position shown in FIG. 88to its fully deployed or extended position shown in FIG. 89. As thecarriage assembly moves toward its deployed position, the collapsiblesidewall 322 a of the collapsible container 322 will move into thecollapsed configuration shown in FIGS. 89 and 89A. As the collapsiblecontainer collapses, the medicinal fluid contained within the containerwill be controllably expelled therefrom through fluid passageway 330 dformed in the penetrating member 330.

To further control the flow of medicinal fluid from reservoir 327 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. Once again, this novel fluid flowcontrol means, comprises two cooperating components, namely a ratecontrol means for controlling the rate of fluid flow from thecollapsible reservoir and an operating means for controlling fluid flowbetween the collapsible reservoir and the rate control means. Thesecomponents are, in this latest embodiment of the invention,substantially identical in construction and operation to those describedin connection with Figure drawings 63 through 76. As previouslymentioned, the penetrating member 330 is of a slightly differentconstruction that is better suited for penetrating top wall 322 s of thecontainer assembly. More particularly, penetrating member 330 has agenerally cylindrically shaped body portion 330 a, an intermediatetapered portion 330 b and a reduced diameter penetrating extremity 330c. Tapered portion 330 b engages tapered sealing wall 324 b forming asubstantially fluid seal.

The rate control means of this latest form of the invention is identicalin construction and operation to that previously described in connectionwith Figure drawings 36 through 74A.

Penetrating member 330 comprises a part of the previously describedpenetrating assembly, which is generally designated in FIGS. 88 and 89by the numeral 288. Support member 316 includes a guide passageway 317,which guides the travel of the penetrating member 330. Assembly 288 alsoincludes a cavity 288 a, which closely receives a portion of the ratecontrol assembly 104.

In this latest embodiment of the invention, selector member housing 242,along with assembly 288 is movable from the first position shown in FIG.88 to the second position shown in FIG. 89. In addition to guiding thetravel of member 242, guide sleeve 250 defines a cylindrical space 250 aabout which the administration line 82 a of the administration set 82can be coiled in the manner best seen in FIG. 88.

As in the earlier described embodiment, selector member housing 242 isretained in its first position by a tear strip 252 that is removablyreceivable between a circumferentially extending rib 242 a formed onhousing 242 and the upper extremity 250 b of guide sleeve 250. When thetear strip 252 is removed, a rotary force exerted on selector memberhousing 242 will move the housing along with the penetrating assemblyinto the second position shown in FIG. 89 and in so doing will cause thepenetrating member 330 to pierce upper wall 322 s in the manner shown inFIG. 89. Piercing of wall 322 s opens a fluid communication path fromreservoir 327 to the rate control assembly 104 via a central fluidpassageway 330 d formed in septum penetrating member 330. Frompassageway 330 d, fluid will flow through conventional particulatefilter 139, into inlet 140 of rate control cover 106 of the rate ofcontrol assembly 104, into inlet 141 of rate control plate 110 and theninto the various circuitous fluid channels of the rate control plate inthe manner previously described. The fluid will then flow into thecircumferentially spaced-apart fluid passageways formed in the selectorhousing 242. In operating the device in the manner previously describedherein, by rotating the selector member 116, which is carried byselector member housing 242, inlet passageway 144 a can be selectivelybrought into index with one of the radial extensions 147 of the axiallyextending passageways formed in selector member 242, thereby providingfluid communication between outlet passageway 148 and the selected oneof the circuitous flow passageways formed in rate control plate 110 viaannular passageway 151 and the selected axially extending passagewayformed in the selector member 242. Since outlet passageway 148 is influid communication with the administration set 82 of the invention viapassageway 151, the rate of fluid flow toward the patient can beprecisely controlled by selecting a rate control passageway ofappropriate length that is formed in rate control plate 110.

Turning next to FIGS. 92 through 96, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 332.This alternate form of dispensing device is similar in many respects tothat shown in FIGS. 88 through 91 and like numerals are used in FIGS. 92through 96 to identify like components.

The major difference between this latest embodiment of the invention andthat shown in FIGS. 88 through 91 resides in the differently configuredreservoir defining container 334. As shown in FIG. 92 container 334,rather than being in the nature of the collapsible bottle, comprises areservoir defining unitary container having a bellows-like sidewall 334a that is movable from the expanded, starting configuration shown inFIG. 92 to the collapsed configuration shown in FIG. 93. This importantreservoir defining container here includes, in addition to sidewall 334a, an interconnected bottom wall 334 b, and an interconnected top wall334 c.

Connected to top wall 334 c and extending therefrom is a Luer-likeconnector 337 having external threads 337 a and a tapered sealing wall337 b. Connector 337, which forms a part of the novel reservoir accessmeans of this latest form of the invention, is interconnected with topwall 334 c at the time of manufacture of the collapsible containerassembly 334. Collapsible container 334 defines a fluid reservoir 337that is accessible via a penetrating member 330 that is similar to thepenetrating member previously described in connection with FIGS. 88 and89 and is adapted to pierce closure wall 335 in the manner previouslydescribed. It is to be noted that tapered portion 330 b of thepenetrating member engages the tapered wall 337 b of container 337 toform a substantially fluid seal.

As indicated in FIGS. 92 and 93 the supporting structure 316 issubstantially identical to the supporting structure of the lastdescribed embodiment. Similarly, the carriage assembly 58 which iscarried within cylindrically shaped outer housing 318 is of identicalconstruction and operation to that previously described and isreleasably locked in its first position by locking means also identicalin construction and operation to the locking means previously describedherein. Carried by carriage assembly 58 in the manner illustrated inFIG. 92 is the previously described reservoir defining container 334.

As in the last described embodiment of the invention, closure wall 335is sealably interconnected with neck portion 337 in accordance with thepreviously described aseptic blow-fill-seal technique. As before, thebasic container 334 is formed using the earlier described aseptic blowfill technique and the reservoir portion of the container is sealed bythe thin closure wall 335.

Once again, in order to controllably move the carriage assembly 58 fromits first position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 58, is here provided in the form of a coiledspring 80, which is also identical in construction and operation to thatpreviously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 318 b of the outer housing 318,spring 80 will move from its compressed position shown in FIG. 92 to itsexpanded position shown in FIG. 93 and in so doing will controllablymove the carriage assembly from its starting position to its fullydeployed or extended position as shown in FIG. 93. As the carriageassembly moves toward its deployed position, the accordion-like,collapsible sidewall 334 a of the collapsible container 334 will moveinto the collapsed configuration shown in FIG. 93. As the containercollapses, the medicinal fluid contained within the container will becontrollably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 337 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. These important flow control means areidentical to those previously described in connection with theembodiment of FIGS. 88 through 91 and will not here be furtherdiscussed.

As in the last described embodiment, selector member housing 242 isretained in its first position by a tear strip 252. When the tear strip252 is removed, a rotary force exerted on selector member housing 242will move the housing along with the penetrating assembly into thesecond position shown in FIG. 93 and in so doing will cause thepenetrating member 330 to pierce the closure wall 335 and sealablyengage sealing wall 337 b.

Piercing of the closure wall 335 opens a fluid communication path fromreservoir 337 to the rate control assembly 104 via a central fluidpassageway 330 d formed in penetrating member 330. From passageway 330d, fluid will flow through conventional particulate filter 139, intoinlet 140 of rate control cover 106 of the rate control assembly 104,into inlet 141 of rate control plate 110 and then into the variouscircuitous fluid channels of the rate control plate in the mannerpreviously described. The fluid will then flow into thecircumferentially spaced-apart fluid passageways formed in the selectorhousing 242. In operating the device in the manner previously describedherein, by rotating the selector member 116, which is carried byselector member housing 242, inlet passageway 144 a can be selectivelybrought into index with one of the radial extensions 147 of the axiallyextending passageways formed in selector member 242, thereby providingfluid communication between outlet passageway 148 and the selected oneof the circuitous flow passageways formed in rate control plate 110 viaannular passageway 151 and the selected axially extending passagewayformed in the selector member 242. Since outlet passageway 148 is influid communication with the administration set 82 of the invention viapassageway 151, the rate of fluid flow toward the patient can beprecisely controlled by selecting a rate control passageway ofappropriate length that is formed in rate control plate 110.

Turning next to FIGS. 97 through 101, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 342.This alternate form of dispensing device is similar in many respects tothat shown in FIGS. 88 through 91 and like numerals are used in FIGS. 97through 101 to identify like components.

The difference between this latest embodiment of the invention and thatshown in FIGS. 88 through 91 resides in the slightly differentlyconfigured reservoir defining container 344 and the slightly differentlyconfigured penetrating assembly 346. As shown in FIG. 97 container 344is similar in most respects to container 322 of FIG. 88 save that the aLuer-like connector 347 has external threads 347 a and is provided witha differently configured sealing wall 349 for sealably engaging theslightly differently configured penetrating member 346 a of penetratingassembly 346.

Reservoir defining container 344 has sidewall 344 a that is movable fromthe expanded, starting configuration shown in FIG. 97 to the collapsedconfiguration shown in FIG. 98. This important reservoir definingcontainer here includes, in addition to sidewall 344 a, aninterconnected bottom wall 344 b, an interconnected top wall 344 c towhich Luer-like connector 347 is attached. Luer-like connector 347 hereforms a part of the novel reservoir access means of the invention.

Collapsible unitary container 344 defines a fluid reservoir 351 that isaccessible via penetrating member 346 a. Penetrating member 346 a herecomprises an elongated body portion 353 and a reduced diameterpenetrating portion 355 that is adapted to pierce closure wall 347 b ofLuer-like connector 347 in the manner shown in FIG. 98. Afterpenetrating portion 355 pierces closure wall 347 b, the taperedinterconnection wall 357, which interconnects body portion 353 andreduced diameter penetrating portion 355, sealably engages sealing wall349 in the manner shown in FIG. 98.

Except for the differently configured collapsible container 344 and thedifferently configured penetrating member 346 a, the apparatus of thislatest form of the invention, including the carriage assembly 58, thelocking means, the stored energy source and a flow control means operatein the same manner to accomplish the same result as the apparatusdiscussed in connection with FIGS. 88 through 91.

Turning next to FIGS. 102 through 106, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 362.This alternate form of dispensing device is similar in many respects tothat shown in FIGS. 97 through 101 and like numerals are used in FIGS.102 through 106 to identify like components.

The difference between this latest embodiment of the invention and thatshown in FIGS. 97 through 101 resides only in the differently configuredreservoir defining container 364. As shown in FIG. 102 container 364,rather than being in the nature of the collapsible bottle, comprises areservoir defining container having a bellows-like sidewall 364 a thatis movable from the expanded, starting configuration shown in FIG. 102to the collapsed configuration shown in FIG. 103. This importantreservoir defining container here includes, in addition to sidewall 364a, an interconnected bottom wall 364 b, and an interconnected top wall364 c.

Connected to top wall 364 c and extending therefrom is a Luer-likeconnector 367 having external threads 367 a and a sealing wall 367 b.Connector 367, which is interconnected with top wall 364 c at the timeof manufacture of the collapsible container assembly 364, here forms apart of the novel reservoir access means of the invention.

Collapsible unitary container 364 defines a fluid reservoir 367 that isaccessible via a penetrating member 346 a that is identical to thepenetrating member previously described in connection with FIGS. 97 and98 and is adapted to pierce closure wall 367 b in the manner previouslydescribed.

Except for the differently configured collapsible container 364, theapparatus of this latest form of the invention, including the carriageassembly 58, the locking means, the stored energy source and a flowcontrol means operate in the same manner to accomplish the same resultas the apparatus discussed in connection with FIGS. 97 through 101.

Referring now to FIGS. 107 through 111, yet another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 372.This alternate form of dispensing device is similar in many respects tothat shown in FIGS. 97 through 101 and like numerals are used in FIGS.107 through 111 to identify like components.

The difference between this latest embodiment of the invention and thatshown in FIGS. 97 through 101 resides in the slightly differentlyconfigured reservoir defining unitary container 374 and the slightlydifferently configured penetrating assembly 376. As shown in FIG. 107container 374 is similar in most respects to container 344 of FIG. 97,save that a Luer-like connector 377 is provided with a differentlyconfigured sealing wall 379 for sealably engaging the slightlydifferently configured penetrating member 376 a of penetrating assembly376. Luer-like connector 377 here forms a part of the novel reservoiraccess means of the invention.

Reservoir defining container 374 has sidewall 374 a that is movable fromthe expanded, starting configuration shown in FIG. 107 to the collapsedconfiguration shown in FIG. 108. This important reservoir definingcontainer here includes, in addition to sidewall 374 a, aninterconnected bottom wall 374 b, an interconnected top wall 374 c towhich Luer-like connector 377 is attached.

Collapsible container 374 defines a fluid reservoir 381 that isaccessible via a punch like penetrating member 376 a. Penetrating member376 a here, rather than comprising an elongated body portion and areduced diameter penetrating portion, comprises a uniform diameter,blunt ended member having an annular cutting element 376 c that isadapted to pierce closure wall 379 of Luer-like connector 377 in themanner shown in FIG. 108. After penetrating closure wall 379, portion376 a, sealably engages sealing wall 379 in the manner shown in FIG.108.

Except for the differently configured collapsible container 374 and thedifferently configured penetrating assembly 376, the apparatus of thislatest form of the invention, including the carriage assembly 58, thelocking means, the stored energy source and a flow control means operatein the same manner to accomplish the same result as the apparatusdiscussed in connection with FIGS. 97 through 101.

Turning next to FIGS. 112 through 116, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 382.This alternate form of dispensing device is similar in most respects tothat shown in FIGS. 107 through 111 and like numerals are used in FIGS.112 through 116 to identify like components.

The difference between this latest embodiment of the invention and thatshown in FIGS. 107 through 111 resides only in the differentlyconfigured reservoir defining unitary container 384. As shown in FIG.112 container 384, rather than being in the nature of the collapsiblebottle, comprises a reservoir defining container having a bellows-likesidewall 384 a that is movable from the expanded, starting configurationshown in FIG. 112 to the collapsed configuration shown in FIG. 113. Thisimportant reservoir defining container here includes, in addition tosidewall 384 a, an interconnected bottom wall 384 b, and aninterconnected top wall 384 c.

Connected to top wall 384 c and extending therefrom is a Luer-likeconnector 387 having external threads 387 a and a sealing wall 387 b.Connector 387, which is interconnected with top wall 384 c at the timeof manufacture of the collapsible container assembly 384, here forms apart of the novel reservoir access means of the invention.

Collapsible container 384 defines a fluid reservoir 389 that isaccessible via a penetrating member 376 a that is identical to thepenetrating member previously described in connection with FIGS. 107 and108 and is adapted to pierce closure wall 387 b in the manner previouslydescribed.

Except for the differently configured collapsible container 384, theapparatus of this latest form of the invention, including the carriageassembly 58, the locking means, the stored energy source and a flowcontrol means operate in the same manner to accomplish the same resultas the apparatus discussed in connection with FIGS. 107 through 111.

Referring next to FIGS. 117 through 122, still another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 392.This alternate form of dispensing device is similar in some respects tothe earlier described embodiments shown in FIGS. 77 through 82 and likenumerals are used in FIGS. 117 through 122 to identify like components.

The primary difference between this latest form of dispensing device andthat previously described in connection with FIGS. 77 through 82 residesin the provision of a novel stored energy source, which is of a totallydifferent construction. More particularly, rather than being in the formof a coil spring, the novel stored energy means of this latest form ofthe invention comprises a compressible, expandable sponge-likeconfiguration, which is generally designated in the drawings by thenumeral 394. This unique stored energy source, which functions to move acarriage 396 from the first compressed position shown in FIG. 117 to thesecond expanded position shown in FIG. 118 can take several forms. Byway of non-limiting example, stored energy source 394 can comprise amicro porous, malodorous, macro-porous, ordered structure and can beconstructed from Polypropylene (PP), Ultra High Molecular WeightPolyethylene (UHMWPE), High Density Polyethylene (HDPE), PolyvinylideneFluoride (PVDF), Ethyle-vinyl Acetate (EVA), Styrene Acrylonitrile(SAN), Polytetrafluroethylene (PTFE) and porous cellulose acetate. Asuitable source of these materials is Porex Technologies of Fairbum, Ga.However, practice has shown that any porous plastic material includingan open cell, porous sponge material is suitable for use in constructingthe stored energy source.

As in the embodiment of the invention shown in FIG. 77, the reservoirdefining assembly 270 here comprises a collapsible container assembly272, which is of identical construction that previously described and iscarried by carriage assembly 396 in the manner illustrated in FIG. 117.

As before, the carriage assembly 396 is releasably secured to baseportion 268 a of the outer housing 268 by a novel locking means. Whenthe locking means of the invention is manipulated in a manner to unlockthe carriage assembly 396 from the base portion 268 a, sponge 394 willexpand from the first compressed position shown in FIG. 117 to thesecond expanded position shown in FIG. 118 and in so doing willcontrollably move the carriage assembly from its starting position shownin FIG. 117 to its more fully deployed or extended position shown inFIG. 118. As the carriage assembly moves toward its deployed position,the sidewall 272 a of the collapsible container 272 will move into thecollapsed configuration shown in FIG. 118. As the collapsible containercollapses, the medicinal fluid contained within the container reservoir277 will be controllably urged outwardly thereof.

To control the flow of medicinal fluid from reservoir 277 toward theadministration set 82 of the invention and then on to the patient, flowcontrol means are provided. Once again, this novel fluid flow controlmeans, comprises two cooperating components, namely a rate control meansfor controlling the rate of fluid flow from the collapsible reservoirand an operating means for controlling fluid flow between thecollapsible reservoir and the rate control means. Both the operatingmeans and the rate control means of this latest form of the inventionare identical in construction and operation to those described inconnection with the embodiment of FIGS. 77 through 82.

As in the earlier described embodiment, the selector member housing 242is retained in its first position by a tear strip 252. When the tearstrip is removed, a rotary force exerted on selector member housing 242will move the housing along with the penetrating assembly 288 into thesecond position shown in FIG. 118 and in so doing will cause thepenetrating member 280 to pierce the membrane 282 as well as the closurewall 274 in the manner shown in FIG. 118. Piercing of the membrane 282and the closure wall 274 opens a fluid communication path from reservoir277 to the rate control assembly 104 via a central fluid passageway 280a formed in penetrating member 280. From reservoir 277, the fluid willflow through central fluid passageway 280 a of penetrating member 280,through conventional particulate filter 139, through the rate controlassembly 104, through the selector member 116 and toward the patient viathe administration set 82.

Referring next to FIGS. 123 through 127, yet another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 402.This alternate form of dispensing apparatus is similar in most respectsto that shown in FIGS. 117 through 122 and like numerals are used inFIGS. 123 through 127 to identify like components. The major differencebetween this latest embodiment of the invention and that shown in FIGS.117 through 122 resides in the differently configured reservoir definingcontainer 404.

As shown in FIGS. 123 and 126, container 404, rather than being in thenature of a collapsible bottle, comprises a reservoir defining containerhaving a bellows-like sidewall 404 a that is movable from the expanded,starting configuration shown in FIG. 123 to the collapsed configurationshown in FIG. 124. This important reservoir defining container hereincludes, in addition to sidewall 404 a, an interconnected bottom wall404 b, an interconnected top wall 404 c and an interconnected neckportion 404 d, which is sealed at the time of manufacture by a thinclosure wall 405. Neck portion 404 d forms a part of the novel reservoiraccess means of the invention. Collapsible container 404 defines a fluidreservoir 407 that is accessible via a penetrating member 280 that isidentical to that previously described. Penetrating member 280 isadapted to pierce closure wall 405 as well as a pierceable membrane 282,which is positioned over closure wall 405 of by means of a closure cap284, which is affixed to the neck portion 404 d of container assembly404.

As best seen in FIGS. 123 and 124 the supporting structure issubstantially identical to the supporting structure of the lastdescribed embodiment and here comprises a connector assembly 266 and agenerally cylindrically shaped outer housing 268 that is interconnectedwith the connector assembly in the manner best seen in FIG. 123 of thedrawings.

Disposed within outer housing 268 is the carriage assembly 396, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly is the previouslydescribed reservoir defining container 404.

As in the last described embodiment of the invention, closure wall 405is sealably interconnected with neck portion 404 d in accordance withthe previously described aseptic blow-fill-seal technique. As before,the basic container 404 is formed using the earlier described asepticblow-fill-seal technique and the reservoir portion of the container issealed by the thin closure wall 405. The piercable membrane 282 is thenpositioned over the closure wall 405 and the cap 284 is positioned overthe piercable membrane and secured to neck portion 404 d by any suitablemeans such as adhesive bonding or sonic welding.

Once again, in order to controllably move the carriage assembly from itsfirst position to its second position, novel stored energy means areprovided. This novel stored energy means, which is operably associatedwith carriage assembly 396, is here provided in the form of acompressible, expandable sponge-like configuration 394, which isidentical in construction and operation to that previously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 268 a of the outer housing 268,sponge 394 will expand and in so doing will controllably move thecarriage assembly from its starting position shown in FIG. 123 to itsfully deployed or extended position shown in FIG. 124. As the carriageassembly moves toward its deployed position, the sidewall 404 a of thecollapsible container 404 will move into the collapsed configurationshown in FIG. 124. As the collapsible container collapses, the medicinalfluid contained within the container will be controllably expelledtherefrom.

To control the flow of medicinal fluid from reservoir 407 toward theadministration set 82 of the invention and then on to the patient, flowcontrol means are provided. Once again, this novel fluid flow controlmeans, comprises two cooperating components, namely a rate control meansfor controlling the rate of fluid flow from the collapsible reservoirand an operating means for controlling fluid flow between thecollapsible reservoir and the rate control means. Both the operatingmeans and the rate control means of this latest form of the inventionare identical in construction and operation to those described inconnection with the embodiment of FIGS. 117 and 118.

As in the earlier described embodiment, selector member housing 242 isretained in its first position by a tear strip 252. When the tear stripis removed, a rotary force exerted on selector member housing 242 willmove the housing along with the penetrating assembly into the secondposition shown in FIG. 124 and in so doing will cause the penetratingmember 280 to pierce the membrane 282 as well as the closure wall 405 inthe manner shown in FIG. 124. Piercing of the membrane 282 and theclosure wall 405 opens a fluid communication path from reservoir 407 tothe rate control assembly 104 via a central fluid passageway 280 aformed in penetrating member 280. From reservoir 407, the fluid willflow through central fluid passageway 280 a of penetrating member 280,through conventional particulate filter 139, through the rate controlassembly 104, through the selector member 116 and toward the patient viathe administration set 82.

Turning next to FIGS. 128 through 132, yet another form of thedispensing device of the present invention for dispensing medicaments toa patient is there shown and generally designated by the numeral 412.This alternate form of dispensing apparatus is similar in many respectsto that shown in FIGS. 123 through 126 and like numerals are used inFIGS. 128 through 132 to identify like components. As best seen in FIGS.128 and 129 the supporting structure 414 is similar in many respects tosupporting structure 264 of FIGS. 123 and 124 and here comprises aconnector assembly 416 and a generally cylindrically shaped outerhousing 418 that is interconnected with the connector assembly in themanner best seen in FIG. 128 of the drawings.

Disposed within outer housing 418 is the carriage assembly 396, which isof identical construction and operation to that described in connectionwith the preceding embodiment and is releasably locked in its firstposition by locking means also identical in construction and operationto the locking means previously described herein. Carried by carriageassembly 396 is a reservoir defining assembly 420, which is of asomewhat different construction. This important reservoir definingassembly here includes a collapsible container assembly 420 having asidewall 420 a, an interconnected bottom wall 420 b and aninterconnected top wall 420 c. Connected to top wall 420 c and extendingtherefrom is a Luer-like connector 422 having external threads 422 a anda sealing wall 422 b. Connector 422, which is interconnected with topwall 420 c at the time of manufacture of the collapsible containerassembly, forms a part of the novel reservoir access means of thislatest form of the invention. Collapsible container assembly 420 definesa fluid reservoir 425 that is accessible via a penetrating member 280that is identical to that previously described and is adapted to piercethe closure wall 422 c of Luer-like connector 422 and sealably engage asealing wall 422 b formed on connector 422.

In the preferred form of this latest alternate embodiment of theinvention, Luer-like connector 422 is integrally formed and sealablyinterconnected with top wall 420 c in accordance with the previouslydescribed aseptic blow-fill-seal technique. In order to controllablymove the carriage assembly from its first position to its secondposition, novel stored energy means are provided. This novel storedenergy means, which is operably associated with carriage assembly 396,is here provided in the form of a compressible, expandable sponge-likeconfiguration 394, which is identical in construction and operation tothat previously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 418 a of the outer housing 418,sponge 394 will expand from its first compressed position shown in FIG.128 to its second, more expanded position shown in FIG. 129 and in sodoing will controllably move the carriage assembly from its startingposition shown in FIG. 128 to its fully deployed or extended positionshown in FIG. 129. As the carriage assembly moves toward its deployedposition, the collapsible sidewall 420 a of the collapsible container420 will move into the collapsed configuration shown in FIG. 129. As thecontainer collapses, the medicinal fluid contained within the containerwill be controllably expelled therefrom.

To further control the flow of medicinal fluid from reservoir 425 towardthe administration set 82 of the invention and then on to the patient,flow control means are provided. These important flow control means areidentical to those previously described in connection with theembodiment of FIGS. 122 and 123 and will not here be further discussed.

As in the last described embodiment, selector member housing 242 isretained in its first position by a tear strip 252. When the tear strip252 is removed, a rotary force exerted on selector member housing 242will move the housing along with the penetrating assembly 288 into thesecond position shown in FIG. 129 and in so doing will cause thepenetrating member 280 to penetrate top wall 422 c of the Luer-likeconnector 422.

Piercing of wall 422 c opens a fluid communication path from reservoir425 to the rate control assembly 104 via a central fluid passageway 280a formed in penetrating member 280. From passageway 280 a, fluid willflow through conventional particulate filter 139, into the inlet of therate of control assembly 104 and into the circumferentially spaced-apartfluid passageways formed in the selector housing 242. In operating thedevice in the manner previously described herein, by rotating theselector member 116, which is carried by selector member housing 242,the rate of fluid flow toward the patient can be precisely controlled byselecting a rate control passageway of appropriate length, width andgeometry that is formed in rate control plate 110.

Turning next to FIGS. 133 and 134, yet another form of the dispensingdevice of the present invention for dispensing medicaments to a patientis there shown and generally designated by the numeral 422. Thisalternate form of dispensing apparatus is similar in many respects tothat shown in FIGS. 128 through 132 and like numerals are used in FIGS.133 and 134 to identify like components. The major difference betweenthis latest embodiment of the invention and that shown in FIGS. 128through 132 resides in the differently configured reservoir definingcontainer 424.

As shown in FIGS. 133 and 134, container 424, rather than being in thenature of the collapsible bottle, comprises a reservoir definingcontainer having a bellows-like sidewall 424 a that is movable from theexpanded, starting configuration shown in FIG. 133 to the collapsedconfiguration shown in FIG. 134. This important reservoir definingcontainer here includes, in addition to sidewall 424 a, aninterconnected bottom wall 424 b, an interconnected top wall 424 c andan interconnected neck portion 424 d, which is integrally formed andsealed at the time of manufacture by a thin closure wall 425. Neckportion 424 d forms a part of the novel reservoir access means of theinvention. Collapsible container 424 defines a fluid reservoir 427 thatis accessible via a penetrating member 280 that is identical to thatpreviously described. Penetrating member 280 is adapted to pierceclosure wall 425 in the manner shown in FIG. 134.

The supporting structure 414 is substantially identical to thesupporting structure of the last described embodiment and here comprisesa connector assembly 416 and a generally cylindrically shaped outerhousing 418 that is interconnected with the connector assembly in themanner best seen in FIG. 133 of the drawings.

Disposed within outer housing 418 is the carriage assembly 396, which isof identical construction and operation to that previously described andis releasably locked in its first position by locking means alsoidentical in construction and operation to the locking means previouslydescribed herein. Carried by carriage assembly is the previouslydescribed reservoir defining container 424.

As in the last described embodiment of the invention, closure wall 425is sealably interconnected with neck portion 424 d in accordance withthe previously described aseptic blow-fill-seal technique. Once again,in order to controllably move the carriage assembly from its firstposition to its second position, novel stored energy means are provided.This novel stored energy means, which is operably associated withcarriage assembly 396, is here provided in the form of a compressible,expandable sponge-like configuration 394, which is identical inconstruction and operation to that previously described.

As in the earlier described embodiments of the invention, when thelocking means of the invention is manipulated in a manner to unlock thecarriage assembly from base portion 418 a of the outer housing 418,sponge 394 will expand and in so doing will controllably move thecarriage assembly from its starting position shown in FIG. 133 to itsfully deployed or extended position shown in FIG. 134. As the carriageassembly moves toward its deployed position, the sidewall 424 a of thecollapsible container 424 will move into the collapsed configurationshown in FIG. 134. As the collapsible container collapses, the medicinalfluid contained within the container will be controllably expelledtherefrom.

To control the flow of medicinal fluid from reservoir 427 toward theadministration set 82 of the invention and then on to the patient, flowcontrol means are provided. Once again, this novel fluid flow controlmeans, comprises two cooperating components, namely a rate control meansfor controlling the rate of fluid flow from the collapsible reservoirand an operating means for controlling fluid flow between thecollapsible reservoir and the rate control means. Both the operatingmeans and the rate control means of this latest form of the inventionare identical in construction and operation to those described inconnection with the embodiment of FIGS. 128 and 129.

As in the earlier described embodiment, selector member housing 242 isretained in its first position by a tear strip 252. When the tear stripis removed, a rotary force exerted on selector member housing 242 willmove the housing along with the penetrating assembly into the secondposition shown in FIG. 134 and in so doing will cause the penetratingmember 280 to pierce the closure wall 425 in the manner shown in FIG.134. Piercing of the closure wall 425 opens a fluid communication pathfrom reservoir 427 to the rate control assembly 104 via a central fluidpassageway 280 a formed in penetrating member 280. From reservoir 427,the fluid will flow through central fluid passageway 280 a ofpenetrating member 280, through conventional particulate filter 139,through the rate control assembly 104, through the selector member 116and toward the patient via the administration set 82.

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

1. A dispensing device for dispensing medicaments to a patientcomprising: (a) a supporting structure; (b) a pre-filled collapsiblecontainer having a continuous wall formed of a single material carriedby said supporting structure, said collapsible container comprising anhermetically sealed reservoir having an outlet port and includingsealing means for sealing said outlet port; (c) stored energy meanscarried by said supporting structure and operably associated with saidcollapsible reservoir for collapsing said collapsible reservoir to expelfluid therefrom; (d) an administration set, including an administrationline interconnected with said outlet of said collapsible reservoir; and(e) fluid flow control means carried by said supporting structure forcontrolling fluid flow from said collapsible reservoir toward saidadministration set.
 2. The dispensing device as defined in claim 1 inwhich said sealing means comprises a pierceable member.
 3. Thedispensing device as defined in claim 1 in which said sealing meanscomprises a shearable member.
 4. The dispensing device as defined inclaim 1 in which said pre-filled collapsible fluid reservoir isaseptically filled and sealed at time of manufacture.
 5. The dispensingdevice as defined in claim 1 in which flow control means comprises ratecontrol means for controlling the rate of fluid flow from saidcollapsible reservoir toward said administration set.
 6. The dispensingdevice as defined in claim 1 in which said stored energy means comprisesa spring operably interconnected with said collapsible reservoir.
 7. Thedispensing device as defined in claim 1 in which said stored energymeans comprises an expandable sponge operably interconnected with saidcollapsible reservoir.
 8. The dispensing device as defined in claim 1 inwhich said flow control means comprises rate control means forcontrolling the rate of fluid flow from said collapsible reservoirtoward said administration set and further comprises operating means forcontrolling fluid flow between said collapsible reservoir and said ratecontrol means.
 9. The dispensing device as defined in claim 8 in whichsaid rate control means includes selector means for selecting the rateof fluid flow between said collapsible reservoir and said administrationset.
 10. The dispensing device as defined in claim 9 in which saidselector means comprises a selector housing carried by said supportingstructure and a selector member rotatably carried by said selectorhousing.
 11. A dispensing device for dispensing medicaments to a patientcomprising: (a) a supporting structure comprising a base assembly and ahousing interconnected with said base assembly; (b) a carriage assemblyinterconnected with said supporting structure for movement between afirst position and a second position; (c) a unitary pre-filledcollapsible container having an uninterrupted wall carried by saidcarriage assembly, said collapsible container comprising a reservoirhaving an outlet port; (d) a stored energy means operably associatedwith said carriage assembly for moving said carriage assembly betweensaid first and second positions, said stored energy means comprising aspring; (e) an administration set, including an administration lineinterconnected with said outlet port of said collapsible reservoir; and(f) fluid flow control means carried by said base assembly of saidsupporting structure for controlling fluid flow from said collapsiblereservoir toward said administration set.
 12. The dispensing device asdefined in claim 11, further including locking means carried by saidsupporting structure for locking said carriage assembly in said firstposition.
 13. The dispensing device as defined in claim 11 in which saidcollapsible container comprises a bellows structure.
 14. The dispensingdevice as defined in claim 11 in which said collapsible containercomprises an hermetically sealed reservoir.
 15. The dispensing device asdefined in claim 11 in which said flow control means comprises: (a) ratecontrol means carried by said supporting structure for controlling therate of fluid flow from said collapsible reservoir toward saidadministration set; and (b) operating means carried by said supportingstructure for controlling fluid flow between said collapsible containerand said rate control means.
 16. The dispensing device as defined inclaim 15 in which said operating means comprises an operating shaftrotatably carried by said base assembly of said supporting structure formovement between a first position blocking fluid flow from saidcollapsible reservoir toward said administration set and a secondposition permitting fluid flow from said collapsible reservoir towardsaid administration set.
 17. The dispensing device as defined in claim16 in which said collapsible container is integrally formed and in whichoutlet port of said reservoir is closed by a frangible member.
 18. Thedispensing device as defined in claim 17 in which said frangible membercomprises a shearable member.
 19. The dispensing device as defined inclaim 18 in which said rate control means includes selector means forselecting the rate of fluid flow between said collapsible reservoir andsaid administration set.
 20. The dispensing device as defined in claim19 in which said selector means comprises a selector housing carried bysaid supporting structure and a selector member rotatably carried bysaid selector housing.
 21. The dispensing device as defined in claim 20in which said rate control means further includes a rate control platehaving a plurality of fluid flow channels interconnected with saidoutlet of said collapsible reservoir.
 22. A dispensing device fordispensing medicaments to a patient comprising: (a) a supportingstructure comprising a base assembly and a generally cylindricallyshaped outer housing interconnected with said base assembly; (b) acarriage assembly interconnected with said supporting structure formovement between a first position and a second position, said carriageassembly comprising a carriage having a carriage base provided with aplurality of circumferentially spaced openings; (c) locking meanscarried by said supporting structure for locking said carriage assemblyin said first position; (d) an aseptically filled collapsible containercarried by said carriage assembly, said collapsible container beingformed by a blow-fill-seal process and having a continuous wallincluding a collapsible side wall, a pierceable top wall connected tosaid collapsible side wall; (e) a stored energy means operablyassociated with said carriage assembly for moving said carriage assemblybetween said first and second positions, said stored energy meanscomprising a coil spring having a first end in engagement with saidsupporting structure and a second end in engagement with said carriage;(f) an administration set, including an administration lineinterconnected with said outlet port of said collapsible reservoir; and(g) fluid flow control means carried by said base assembly of saidsupporting structure for controlling fluid flow from said collapsiblereservoir toward said administration set, said flow control meanscomprising: (i) rate control means carried by said supporting structurefor controlling the rate of fluid flow from said collapsible reservoirtoward said administration set, said rate control means comprising arate control plate having a plurality of fluid flow channelsinterconnected with said outlet of said collapsible reservoir; and (ii)operating means carried by said supporting structure for controllingfluid flow between said collapsible reservoir and said rate controlmeans.
 23. A dispensing device as defined in claim 22 further includingguide means connected to said supporting structure for guiding travel ofsaid carriage assembly between said first position and said secondposition, said guide means comprising a plurality of circumferentiallyspaced guide members connected to said base assembly and a guide ribconnected to said housing of said supporting structure, saidspaced-apart guide members being slidably received within said openingsprovided in said carriage base.
 24. The dispensing device as defined inclaim 22 in which said operating means comprises a penetrating membermovable between first position and a second position permitting fluidflow from said collapsible reservoir toward said administration set. 25.The dispensing device as defined in claim 22 in which said collapsiblecontainer comprises a bellows structure.
 26. The dispensing device asdefined in claim 22 in which said rate control means further includesselector means for selecting the rate of fluid flow between saidcollapsible reservoir and said administration set, said selector meanscomprising a selector housing carried by said supporting structure and aselector member rotatably carried by said selector housing.
 27. Thedispensing device as defined in claim 22 further including a pierceableseptum connected to said collapsible container.
 28. The dispensingdevice as defined in claim 26 in which said pierceable septum comprisesa slit septum.
 29. A dispensing device for dispensing medicaments to apatient comprising: (a) a supporting structure; (b) a hermeticallysealed, unitary collapsible container carried by said supportingstructure, said unitary collapsible container being formed using asepticblow-fill-seal manufacturing techniques and having a pre-filled, sealedfluid reservoir filled with the fluid to be delivered to the patient;(c) access means connected to said collapsible container for accessingsaid reservoir; (d) a stored energy means operably associated with saidsupporting structure for collapsing said collapsible container; and (e)an administration set, including an administration line interconnectedwith said outlet port of said collapsible reservoir.
 30. The dispensingdevice as defined in claim 29 in which said collapsible containercomprises a bellows structure.
 31. The dispensing device as defined inclaim 29 in which said collapsible container comprises a telescopingside wall.
 32. The dispensing device as defined in claim 29 in whichsaid stored energy means comprises a spring operably interconnected withsaid carriage assembly.
 33. The dispensing device as defined in claim29, further including a carriage assembly carried by said supportingstructure for supporting said hermetically sealed collapsible container,said carriage assembly being movable between first and second positions.34. The dispensing device as defined in claim 29 in which said storedenergy means comprises a compressible, expandable member operablyinterconnected with said carriage assembly.
 35. The dispensing device asdefined in claim 29 in which the fluid contained within said reservoircomprises a diluent.
 36. The dispensing device as defined in claim 29 inwhich the fluid contained within said reservoir comprises a beneficialagent.
 37. The dispensing device as defined in claim 29 in which thefluid contained within said reservoir comprises a blood volume expander.38. The dispensing device as defined in claim 29 in which the fluidcontained within said reservoir comprises artificial blood substitute.39. The dispensing device as defined in claim 29 in which the fluidcontained within said reservoir comprises a saline solution.
 40. Thedispensing device as defined in claim 29 in which the fluid containedwithin said reservoir comprises blood plasma.
 41. The dispensing deviceas defined in claim 29 in which the fluid contained within saidreservoir comprises a nutritional solution.
 42. The dispensing device asdefined in claim 29 in which the fluid contained within said reservoircomprises blood.
 43. The dispensing device as defined in claim 29 inwhich the fluid contained within said reservoir comprises resuscitationfluid.
 44. The dispensing device as defined in claim 29 in which thefluid contained within said reservoir comprises a biologic.
 45. Thedispensing device as defined in claim 29, further including a carriageassembly carried by said supporting structure for supporting saidhermetically sealed collapsible container and in which said supportingstructure comprises a base assembly and a housing interconnected withsaid base assembly and further comprising guide means for guiding saidcarriage, said guide means comprising a guide member connected to saidbase assembly, said carriage assembly being slidably associated withsaid guide member.
 46. The dispensing device as defined in claim 28, inwhich said accessing means comprises a Luer-like connector connected tosaid collapsible container and a pierceable membrane carried by saidLuer-like connector.
 47. The dispensing device as defined in claim 28,in which said accessing means includes an integrally formed closurewall.
 48. The dispensing device as defined in claim 28, furtherincluding fluid flow control means carried by said supporting structurefor controlling fluid flow from said collapsible reservoir toward saidadministration set.
 49. The dispensing device as defined in claim 28 inwhich said accessing means comprises a neck portion connected to saidcollapsible container and a pierceable septum carried by said neckportion.
 50. The dispensing device as defined in claim 28 in which saidaccessing means comprises a neck portion connected to said collapsiblecontainer and a pierceable sealing wall integrally formed with said neckportion.
 51. The dispensing device as defined in claim 28 in which saidaccessing means comprises a neck portion connected to said collapsiblecontainer and a pierceable elastomeric member carried by said neckportion.
 52. The dispensing device as defined in claim 28, in which saidaccessing means comprises a neck portion connected to said collapsiblecontainer, a pierceable septum carried by said neck portion and asealing wall integrally formed with said collapsible container.
 53. Thedispensing device as defined in claim 28, in which said accessing meanscomprises a neck portion connected to said collapsible container and apierceable slit septum carried by said neck portion.
 54. The dispensingdevice as defined in claim 28, in which said accessing means comprises aneck portion connected to said collapsible container, a pierceable slitseptum carried by said neck portion and a sealing wall integrally formedwith said collapsible container.
 55. A fluid dispensing devicecomprising: (a) a supporting structure; (b) a pre-filled sealed,collapsible container carried by said supporting structure, saidcollapsible container including a fluid reservoir and being integrallyformed as a single unit at time of manufacture; (c) stored energy meanscarried by said supporting structure and operably associated with saidcollapsible container for collapsing said collapsible container tocontrollably expel fluid from said fluid reservoir; (d) anadministration set, including an administration line interconnected withsaid fluid reservoir; and (e) fluid flow control means carried by saidsupporting structure for controlling fluid flow from said fluidreservoir toward said administration set, said flow control meanscomprising: (i) rate control means for controlling the rate of fluidflow from said fluid reservoir toward said administration set; and (ii)operating means for controlling fluid flow between said collapsiblereservoir and said rate control means.
 56. The fluid dispensing deviceas defined in claim 49 in which said operating means comprises anoperating shaft rotatably carried by said supporting structure formovement between first position blocking fluid flow from said fluidreservoir toward said administration set and a second positionpermitting fluid flow from said fluid reservoir toward saidadministration set.
 57. The dispensing device as defined in claim 49 inwhich said rate control means comprises a rate control plate having atleast one fluid flow channel interconnected with said fluid reservoir.58. The dispensing device as defined in claim 49 in which said ratecontrol means comprises a rate control plate having at least one fluidflow micro-channel interconnected with said fluid reservoir.
 59. Thedispensing device as defined in claim 49 in which said rate controlmeans comprises a rate control plate having at least one fluid flowmicro-channel interconnected with said fluid reservoir, said fluid flowmicro-channel having a surface coating.
 60. The dispensing device asdefined in claim 49 in which said rate control means comprises a ratecontrol plate having a plurality of micro-channels of varying length,width, depth and geometry interconnected with said fluid reservoir. 61.The dispensing device as defined in claim 49 in which said rate controlmeans further includes selector means for selecting the rate of fluidflow between said fluid reservoir and said administration set, saidselector means comprising a selector housing carried by said supportingstructure and a selector member rotatably carried by said selectorhousing.
 62. The dispensing device as defined in claim 49 in which saidoperating means comprises a penetrating member movable between firstposition and a second position permitting fluid flow from said fluidreservoir toward said administration set.
 63. The dispensing device asdefined in claim 56 in which said penetrating member comprises a septumpenetrating member.
 64. The dispensing device as defined in claim 56 inwhich said penetrating member comprises a septum penetrating memberhaving an elastomeric coating.
 65. The dispensing device as defined inclaim 56 in which said penetrating member comprises a septum penetratingmember having sharp penetrating extremity.
 66. The dispensing device asdefined in claim 56 in which said penetrating member comprises a septumpenetrating member having a blunt-end penetrating extremity.
 67. Thedispensing device as defined in claim 56 in which said penetratingmember includes a tapered portion.
 68. The fluid dispensing device asdefined in claim 56 in which said collapsible container, includesaccessing means for accessing said fluid reservoir.
 69. The fluiddispensing device as defined in claim 62 in which said accessing meanscomprises a frangible member.
 70. The fluid dispensing device as definedin claim 62 in which said accessing means comprises a shearable member.71. The fluid dispensing device as defined in claim 62 in which saidaccessing means comprises an elastomeric member.
 72. The fluiddispensing device as defined in claim 62 in which said accessing meanscomprises a slit septum.
 73. The fluid dispensing device as defined inclaim 62 in which said accessing means comprises a sealing wall.